Dig Dis Sci DOI 10.1007/s10620-015-3933-0
REVIEW
Endoscopic Ultrasound-Guided Biliary Drainage: A Systematic Review and Meta-Analysis Muhammad Ali Khan1 • Ali Akbar1 • Todd H. Baron3 • Sobia Khan2 • Mehmat Kocak4 • Yaseen Alastal2 • Tariq Hammad2 • Wade M. Lee5 • Aijaz Sofi2 • Everson L. A. Artifon6 • Ali Nawras2 • Mohammad Kashif Ismail1
Received: 3 June 2015 / Accepted: 13 October 2015 Ó Springer Science+Business Media New York 2015
Abstract Background and Aims Variable success and adverse event rates have been reported for endoscopic ultrasoundguided biliary drainage (EUS-BD) utilizing either extrahepatic or intrahepatic approach. We aimed to conduct a proportion meta-analysis to evaluate the cumulative efficacy and safety of EUS-BD and to compare the two approaches and transluminal methods of EUS-BD. Methods We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, ISI Web of Science, and Scopus from January 2001 through January 5, 2015, to
& Mohammad Kashif Ismail
[email protected] Muhammad Ali Khan
[email protected] 1
Division of Gastroenterology, University of Tennessee Health Science Center, 956 Court Avenue, Suite H210, Memphis, TN 38163, USA
2
Division of Gastroenterology, University of Toledo, Toledo, OH, USA
3
Division of Gastroenterology, University of North Carolina, Chapel Hill, NC, USA
4
Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA
5
Carlson and Mulford Libraries, University of Toledo, Toledo, OH, USA
6
Division of Gastroenterology, University of Sao Paulo, Sa˜o Paulo, Brazil
identify studies reporting technical success and adverse events of EUS-BD. A sample size of more than 20 patients was a further criterion. Weighted pooled rate (WPR) for technical success and post-procedure complications was calculated for overall studies and predefined subgroups. Pooled odds ratios were calculated for technical success and adverse events for two approaches and transluminal methods of EUS-BD for distal common bile duct (CBD) strictures. Results The WPR with 95 % confidence interval (CI) for technical success and post-procedure adverse events was 90 % (86, 93 %) and 17 % (13, 22 %), respectively, with considerable heterogeneity (I2 = 77 %). For high-quality studies, the WPR for technical success was 94 % (91, 96 %), I2 = 0 % and WPR for post-procedure adverse event was 16 % (12, 19 %), I2 = 39 %. In meta-regression model, distal CBD stricture and transpapillary drainage were associated with higher technical success and intrahepatic access route was associated with higher adverse event rate. There was no difference in technical success using either approach OR 1.27 (0.52, 3.13), I2 = 0 % or transluminal method OR 1.32 (0.51, 3.38), I2 = 0 %. However, the extrahepatic approach appeared significantly safer as compared to the intrahepatic approach OR 0.35 (0.19, 0.67), I2 = 27 %. Likewise, choledochoduodenostomy was found to have less adverse events as compared to hepaticogastrostomy, OR 0.40 (0.18, 0.87), I2 = 0 %. Conclusion In cases of failure of traditional ERC to achieve biliary drainage, EUS-BD appears to be an emerging therapeutic modality with a cumulative success rate of 90 % and cumulative adverse events rate of 17 %. Randomized controlled trials are required to further evaluate the efficacy and safety of the procedure along with the comparison to traditional modalities like percutaneous transhepatic biliary drainage.
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Keywords EUS-BD Choledochoduodenostomy Hepaticogastrostomy Antegrade biliary drainage Rendezvous
Introduction Endoscopic retrograde cholangiography (ERC) with stent placement is the procedure of choice for relief of biliary obstruction. The success rate of ERC is [90 % [1–3]. Failure of ERC can be attributed to surgically altered anatomy, duodenal obstruction, gastric outlet obstruction, in situ enteral stents, periampullary diverticula, or periampullary tumor infiltration [4]. Conventionally, such patients undergo percutaneous transhepatic biliary drainage (PTBD). However, PTBD is associated with substantial morbidity in the form of catheter dislodgement, recurrent infection, acute cholangitis, pneumothorax, and cosmetic problems (due to external drainage) [5]. This may lead to poor outcomes and decline in quality of life [6, 7]. Endoscopic ultrasound-guided biliary drainage (EUSBD) is a relatively new therapeutic modality in the arsenal of endoscopists for attaining satisfactory biliary drainage when traditional ERC fails. It was first described by Giovannini et al. [8] in 2001. Subsequently, several groups described the efficacy of EUS-BD, suggesting it is an effective alternative in place of PTBD or biliary bypass surgery. EUS-BD can be performed by two major approaches: extrahepatic (EH) and intrahepatic (IH). In the EH approach, the common bile duct is accessed mainly through the duodenum or through the gastric antrum. Biliary drainage can be achieved by either transluminal stent placement (choledochoduodenostomy) or transpapillary stent placement via the rendezvous technique. On the other hand, when the IH approach is used the left lobe of the liver is accessed from the gastric wall and rarely from the distal esophagus or jejunum. Using this approach, biliary drainage can be attained by either transluminal stent placement (hepaticogastrostomy) or transpapillary stent placement via rendezvous technique or antegrade technique [9]. Published studies have reported variable rates of success and adverse events utilizing the different approaches and methods of EUS-BD. It is unknown how extrahepatic and intrahepatic approaches for EUS-BD compare in terms of efficacy and safety. Therefore, we conducted a systematic review and proportion meta-analysis to evaluate the cumulative efficacy and safety of EUS-BD. Subsequently, we also performed meta-analyses evaluating not only the efficacy and safety of the extrahepatic and intrahepatic approaches, but also of the two major transluminal methods (choledochoduodenostomy and hepaticogastrostomy) utilized for EUS-BD.
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Methods Data Sources and Search Strategy The systematic review was carried out in accordance with the preferred reporting items for systematic reviews and metaanalyses (PRISMA) guidelines [10] and meta-analysis of observational studies in epidemiology (MOOSE) guidelines [11]. The search strategies were developed in PubMed and translated to match the subject headings and keywords for Embase, Cochrane Central Register of Controlled Trials, ISI Web of Science, and Scopus from January 2001 through January 5, 2015. The following MeSH, Emtree, and keyword search terms were used in combination: biliary drainage, biliary stent, transpapillary biliary drainage, transluminal biliary drainage, choledochoduodenostomy, hepaticogastrostomy, rendezvous, antegrade biliary stent, endoscopic ultrasound guided, EUS-BD, EUS-guided biliary drainage, therapeutic EUS, endoscopic anterograde cholangiography, and interventional EUS. Published abstracts or unpublished data were not included [12, 13]. Study Selection and Data Extraction Eligibility criteria were determined a priori by three study authors (MAK, AA, and THB) and included EUS-guided biliary drainage achieved with either extrahepatic or intrahepatic approach, utilizing transpapillary (anterograde and/or retrograde) or transluminal stenting. Studies were only included if they reported technical success (defined as successful stent placement as determined endoscopically) and procedure-related adverse events. Small case series and case reports were excluded to minimize inherent bias associated with them [14]. We accomplished this by setting an arbitrary figure of 20 for the minimum number of patients as part of the inclusion criteria. Studies were excluded if they reported experimental data on animals or if data were included in a more recently published study in which case the most recent study was included. Two independent reviewers (AA and MKI) reviewed the title and abstract search with inclusion decisions for each study made independently based on the eligibility criteria. Any disagreement between reviewers was discussed with a third reviewer (THB) and agreement was reached by consensus. Extracted data included study design, country and year of study, patient demographics, benign versus malignant cause of biliary obstruction, technical success of EUSBD, post-procedure adverse events and—wherever available—the approach utilized (extrahepatic versus intrahepatic), method of drainage (choledochoduodenostomy, hepaticogastrostomy, antegrade stenting, or rendezvous), and clinical success.
Dig Dis Sci
Data Synthesis and Statistical Analysis
Quality Assessment
Our primary outcomes of interest were efficacy of EUS-BD assessed by predefined technical success, clinical success (defined as reduction in serum total bilirubin by 50 % at 2 weeks), and safety of EUS-BD assessed by post-procedural adverse events. Weighted pooled rates were calculated for the primary outcomes of interest with corresponding 95 % confidence intervals (CI). These were analyzed using the random-effects model (DerSimonianLaird method) [15] and corresponding cumulative analysis forest plots were constructed. Heterogeneity across the studies was assessed using the Cochran Q test and I2 statistics. A p value of\0.1 for Cochran Q test was defined as indicating the presence of heterogeneity [16]. Publication bias was assessed through funnel plots and Begg– Mazumdar test [17]. If asymmetry was detected, we evaluated the potential effect of publication bias using the Duval and Tweedie nonparametric ‘trim-and-fill’ test to recalculate the effect size. Subgroup analysis and meta-regression were done to explore any heterogeneity. Subgroups were divided based on the quality of studies, and weighted pooled rates were calculated for technical success and post-procedure adverse events along with corresponding 95 % CI. The effects of distal location of stricture, routes of biliary drainage (extrahepatic and intrahepatic), and methods of biliary drainage (transluminal and transpapillary) on the cumulative safety and efficacy were analyzed with meta-regression using the random-effects model (methods of moments) [18]. Our secondary outcome of interest was to evaluate the technical success and adverse events of EUS-BD in distal biliary strictures depending on the approach utilized (extrahepatic or intrahepatic) and methods of transluminal drainage (choledochoduodenostomy versus hepaticogastrostomy) to access the biliary tree. Odds ratios (OR) of technical success and adverse events were calculated using the raw data with corresponding 95 % CI, and corresponding forest plots were constructed. Sensitivity analysis was carried out using a fixed-effects method of metaanalysis. Cochran Q test and I2 statistics were used to assess for heterogeneity across studies. Publication bias was assessed by funnel plot and Egger’s test. In the presence of asymmetry, we used the trim-and-fill test to recalculate effect size. Corresponding authors of studies were contacted when either required data were not available or there was a possibility of study data being included in a subsequent multicenter study [19–22]. Authors who replied have been acknowledged in the manuscript. All statistical analyses were conducted using Comprehensive Meta-analysis software (version 3.0; Biostat; Englewood, NJ, USA).
Quality assessment was done by two authors (TH and YA) independently, using the Newcastle–Ottawa scale (NOS) for cohort studies [23] and Jadad scale for randomized trials [24]. Any disagreement between reviewers was to be discussed with a third reviewer (MKI) with agreement to be reached by consensus. The NOS assessment scale utilizes a tool that measures quality in three parameters of selection, comparability, and exposure/outcome and allocates a maximum of four, two, and three points, respectively. High-quality studies are scored [7 on this scale and moderate-quality studies between 5 and 7. The Jadad scale assigns one point each for randomization, appropriate method of randomization, double blinding and appropriate method of double blinding, and description of dropouts. High-quality studies score between 3 and 5, while low-quality studies score less than 3.
Results Search Strategy Yield, Study Characteristics and Quality Assessment The search strategy identified 1521 publications, of which 679 were removed as duplicate publications and 767 were excluded based on title and abstract review. Backward snowballing of 75 articles revealed 1 additional study. The Cohen’s kappa value between the reviewers for inclusion of studies was 0.92. A multicenter retrospective study [19] included data from two studies [25, 26]. Dhir et al. [27] also reported a multicenter retrospective analysis which included data from one other single-center study [28]. A total of 20 studies were included in the meta-analysis. Out of these 19 were observational studies [19–22, 27, 29–42] and 1 was a randomized trial [43]. Figure 1 summarizes the study selection process. The characteristics of included studies are illustrated in Tables 1 and 2. A total of 1186 patients (ranging from 21 to 234 patients in different studies) were included in the proportion meta-analysis. Only one study did not specify the approach utilized for biliary drainage [31]. Four other studies [30–32, 42] did not include any transluminal biliary drainage. Six studies [19, 20, 30, 32, 37, 42] did not report the corresponding clinical success attained in technically successful procedures. For grading the severity of post-procedural adverse events, five studies [21, 27, 29, 40, 41] utilized the American Society for Gastrointestinal Endoscopy (ASGE) lexicon [44] and one study [32] used the consensus criteria [45]. Using the NOS assessment, 9 observational studies [21, 27, 29, 32, 34, 37, 39–41] were found to be of high-quality and 10 observational studies [19, 20, 22, 30, 31, 33, 35, 36, 38, 42] were labeled as moderate-quality studies. The randomized trial [43] was found to be of high quality as per
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1521 records identified from database search 679 records removed as duplicates
842 records screened after duplicates removal
767 records excluded after title and abstract review
75 full-text articles from database search reviewed 1 record identified by backward snowballing
76 full-text articles assessed for eligibility
56 articles excluded after full-text review. • • • •
20 studies included in analysis • •
19 observational studies 1 randomized trial
•
•
Review articles = 16 Studies with no relevant data = 4 Animal studies = 2 Ineligible sample size = 12 Studies included in a subsequent larger study =3 Conference abstracts= 19
Fig. 1 Flowchart for study selection process (PRISMA)
the Jadad scale (Appendix 1). The Cohen’s kappa value between the reviewers for assessing quality was 0.96. Meta-Analyses Overall Efficacy and Safety of EUS-BD A total of 20 studies were included to evaluate the technical success and safety of EUS-BD. The WPR for technical success was 90 % with a 95 % CI (86, 93 %) (Fig. 2), (Cochran Q test P \ 0.0001, I2 = 77.6 %). Funnel plot appeared asymmetric, but Begg–Mazumdar test (s = 0.2157; P = 0.183 two-tailed) failed to show evidence of publication bias (Appendix 2). Subgroup analysis was done based on the quality of studies. High-quality studies were pooled separately from moderate-quality studies. The WPR for technical success of high-quality studies was 94 % with a 95 % CI (91, 96 %) (Fig. 3; Cochran Q test P = 0.62, I2 = 0 %). For moderate-quality studies, the weighted pooled technical success rate was
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85 % with a 95 % CI (79, 91 %) (Cochran Q test P \ 0.0001, I2 = 82.7 %). Five covariates viz. distal location of stricture in common bile duct, method of biliary drainage (transluminal and transpapillary), and route of access (extrahepatic and intrahepatic) were included in a meta-regression model to further explore heterogeneity (Table 3). Distal location of stricture was associated with a higher technical success rate (coefficient = -1.367; SE = 0.35; P = 0.0001), and transpapillary method of drainage was also associated with higher success rate (coefficient = -1.185; SE = 0.40; P = 0.0037). R2 analogue for the model was 0.91. The WPR for clinical success was 94 % with a 95 % CI (91, 96 %) (Fig. 4), (Cochran Q test P = 0.198, I2 = 24.26 %). Funnel plot appeared asymmetric, but Begg–Mazumdar test (s = 0.311; P = 0.143 two-tailed) did not detect publication bias (Appendix 3). The WPR for post-procedure adverse events was 17 % with a 95 % CI (13, 22 %) (Fig. 5) (Cochran Q test P \ 0.0001, I2 = 77 %). The funnel plot appeared
Design and country
Prospective cohort study; single center; South Korea
Retrospective cohort; single center; Thailand
Retrospective cohort; multicenter; Spain
Retrospective cohort; Multicenter; International
Retrospective cohort; multicenter; USA
Retrospective cohort; multicenter; Japan
Retrospective cohort study; single center; USA
Retrospective cohort study; single center; USA
Retrospective cohort; Multicenter; International
Prospective randomized trial; single center; Brazil
References
Park et al. [29]
Attasaranya et al. [33]
Vila et al. [22]
Gupta et al. [19]
Khashab et al. [21]
Kawakubo et al. [37]
Shah et al. [31]
Iwashitaet al. [30]
Dhir et al. [27]
Artifon et al. [43]
49
104
40
66
64
35
234
106
27
57
N
66 (median)
66.72 (mean)
73 (median)
65 (mean)
72 (median)
66.1 (mean)
67.3 (mean)
69.03 (mean)
58.0 (mean)
61.7 (mean)
Age in years
24
46
23
30
29
17
115
49
17
22
Female
Table 1 Study characteristics, patient demographics, and quality assessment
49/0
104/0
28/12
42/24
64/0
35/0
194/40
87/19
22/9
51/6
Malignant/ benign
Distal strictures only
Distal strictures only
Proximal and distal strictures
Proximal and distal strictures
Proximal and distal strictures
Distal strictures only
Proximal and distal strictures
Proximal and distal strictures
Proximal and distal strictures
Proximal and distal strictures
Proximal and distal stricture vs distal stricture only
EH: 17 (CDS) IH: 22 (HGS) IH: 24 (HGS) IH:25 (HGS)
IH: 32 (AG) EH: 22 (CDS)
IH: 36 (AG)
93/97 overall
NR
13 (AG)
37 (RV)
EH: 24 (CDS)
EH: 65 (CDS)
IH: 4 (RV)
IH: 9 (RV) EH: 68 (CDS)
EH: 25 (RV)
EH: 31 (RV)
13 (AG)
16 (AG)
IH: 19 (HGS) 37 (RV)
IH: 20 (HGS) 50 (RV)
2 (RV)
2 (RV)
NR
2 (HES)
2 (HES) 2 (HES)
EH: 42 (CDS)
IH: 3 (HGS)
IH: 3 (HGS) IH: 3 (HGS)
EH: 44 (CDS)
11 (RV)
11 (RV) 11 (RV)
2 (RV)
EH: 14 (CDS)
NR EH: 15 (CDS)
IH: 132
IH: 20 (HGS) IH: 7 (RV)
EH: 24 (RV)
EH: 18 (CDS)
EH: 17 (CDS)
EH: 75
IH: 145
IH: 8 (RV)
IH: 22 (HGS)
EH: 24 (RV)
EH:19 (CDS)
IH: 13 (HGS)
Jadad = 3
NOS = 8
NOS = 6
NOS = 5
NOS = 8
NOS = 8
NOS = 6
NOS = 6
1 (AG)
1 (AG) IH: 13 (HGS)
NOS = 5
EH: 5 (CDS)
EH: 6 (CDS)
NOS or jadad assessment NOS = 8
Clinical success EH: 22 (CDS) IH: 27 (HGS)
EH: 24 (CDS) IH: 31 (HGS)
Technical success
EH: 89
IH: 34 (HGS) 12 (RV)
34 (RV)
EH: 26 (CDS)
IH: 16 (HGS)
1 (AG)
EH: 10 (CDS)
EH: 26 (CDS) IH: 31 (HGS)
Method of drainage
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Design and country
Retrospective cohort; single center; India
Retrospective cohort; multicenter; International
Retrospective cohort; single center; USA
Retrospective cohort; single center; Thailand
Retrospective; single center; India
Retrospective cohort; single center; Brazil
Prospective cohort; single center; New Zealand
References
Bapaye et al. [36]
Dhir et al. [20]
Khashab et al. [41]
Prachayakul et al. [34]
Dhir et al. [32]
Takada et al. [35]
Weilert [39]
Table 1 continued
123 21
32
58
22
22
68
25
N
67.4 (mean)
67 (mean)
49 (median)
62.8 (mean)
64.9 (mean)
NR
59.9 (mean)
Age in years
9
15
36
10
10
34
12
Female
16/5
32/0
43/15
22/0
22/0
68/0
25/0
Malignant/ benign
Proximal and distal strictures
Distal strictures only
Distal strictures only
Proximal and distal strictures
Distal strictures only
Distal strictures only
Distal strictures only
Proximal and distal stricture vs distal stricture only
2 (CAS) 1 (RV) IH: 6 (HGS) 2 (AG) 1 (HJS) 19 total
1 (RV) IH: 6 (HGS) 2 (AG) 1 (HJS) EH: 1 (CDS) IH: 10 (HGS) 7 (AG) 2 (RV)
EH: 1 (CDS) IH: 10 (HGS) 7 (AG) 3 (RV)
1 (HJS)
2 (AG)
1 (RV) IH: 7 (HGS)
2 (CAS)
2 (CAS)
NR EH: 17 (CDS)
EH: 57 (RV) EH: 17 (CDS) EH:19 (CDS)
EH: 58 (RV)
IH: 15 (HGS)
IH: 16 (HGS)
1 (RV) 1 (RV) 1 (RV)
19 total
1 (HES) 1 (HES) 1 (HES)
EH: 6 (CDS)
IH: 1 (HGS) IH: 1 (HGS)
EH: 6 (CDS)
5 (RV) 5 (RV)
IH: 1 (HGS)
11 (RV)
11 (RV)
5 (RV)
15 (AG)
15 (AG)
EH: 11 (CDS)
IH: 8 (HGS)
IH: 8 (HGS)
EH: 11 (CDS)
9 (RV)
9 (RV)
NR
IH: 5 (AG)
IH: 5 (HGS)
EH:13 (CDS)
Clinical success
EH: 14 (CDS)
EH: 22 (CDS)
IH: 5 (AG)
IH: 5 (AG) EH: 25 (CDS)
EH: 13 (CDS) IH: 5 (HGS)
Technical success
EH: 13 (CDS) IH: 7 (HGS)
Method of drainage
NOS = 8
NOS = 7
NOS = 7
NOS = 8
NOS = 8
NOS = 6
NOS = 6
NOS or jadad assessment
Dig Dis Sci
IH: 16 (RV) IH: 17 (RV)
EH extrahepatic, IH intrahepatic, CDS choledochoduodenostomy, CAS choledochoantrostomy; HGS hepaticogastrostomy, HES hepaticoesophagostomy, HJS hepaticojejunostomy, AG antegrade, RV rendezvous, NR not reported, NOS Newcastle–Ottawa scale
NOS = 7 NR EH: 18 (RV) EH: 18 (RV) 35 Retrospective cohort; single center; India Dhir et al. [42]
53.44 (mean)
13
24/11
Distal strictures only
IH: 10 (HGS)
IH: 10 (HGS)
EH: 17 (CDS)
IH: 10 (HGS)
13 (AG)
EH: 17 (CDS) Proximal and distal strictures 27/0 14 67 (median) 27
Prospective cohort; single center; South Korea Song et al. [40]
49 (HGS)
IH: 19 (RV)
EH: 16 (CDS)
NOS = 8
NOS = 7 79 total EH: 13 IH: 67 EH: 9 (CDS) 4 (CAS) 94 Prospective cohort; single center; Germany Will et al. [38]
67 (mean)
49
77/17
Proximal and distal strictures
Clinical success Technical success N Design and country References
Table 1 continued
Age in years
Female
Malignant/ benign
Proximal and distal stricture vs distal stricture only
Method of drainage
NOS or jadad assessment
Dig Dis Sci
asymmetric and Begg–Mazumdar test confirmed publication bias (s = -0.305; P = 0.03 two-tailed) (Appendix 4). Utilization of the trim-and-fill test revealed adjusted postprocedure adverse events rate of 22 % with a 95 % CI (17, 28 %). Subgroup analysis was done based on quality of studies. The WPR for post-procedure adverse event rate of high-quality studies was 16 % with a 95 % CI (12, 19 %) (Fig. 6) (Cochran Q test P = 0.097, I2 = 39.1 %), while the weighted pooled post-procedure adverse event rate for moderate-quality studies was 19 % with a 95 % CI (12, 27 %) (Cochran Q test P \ 0.0001, I2 = 82.7 %). For meta-regression analysis, distal location of stricture and route of access (extrahepatic and intrahepatic) were analyzed in the model. Only intrahepatic route of access was associated with higher adverse events rate (coefficient = 2.236; SE = 0.739; P = 0.0025). The R2 analogue for the model was 0.78 (Table 4). Efficacy and Safety Based on Approach (Extrahepatic Versus Intrahepatic) in Distal CBD Strictures Eight studies [20, 21, 27, 35, 36, 41–43] evaluated the technical success based on the approach in distal biliary strictures and were included in this analysis. The pooled OR (95 % CI) was 1.27 (0.52–3.13) (Cochran Q test P = 0.60, I2 = 0 %; Fig. 7). There was no visual evidence of funnel asymmetry and Egger’s test failed to show any publication bias (P = 0.38) (Appendix 5). The same eight studies also evaluated the post-procedure adverse events (safety) based on the extrahepatic versus intrahepatic approach. The pooled OR (95 % CI) was 0.35 (0.19–0.67), in favor of the extrahepatic approach (Cochran Q test P = 0.21, I2 = 27 %; Fig. 8). A sensitivity analysis was done as one study [42] appeared to be an outlier. Recalculated effect size for the remaining seven studies was 0.46 (0.23, 0.90) in favor of extrahepatic approach (Cochran Q test P = 0.58, I2 = 0 %). Funnel plot appeared asymmetric, but Egger’s test did not reveal any publication bias (P = 0.51) (Appendix 6). Publication bias should be interpreted with caution in these analyses as the total number of studies is less than ten. Efficacy and Safety Based on Method of Transluminal Drainage in Distal CBD Strictures Seven studies [20, 21, 27, 35, 36, 41, 43] reported technical success based on the method of transluminal drainage (choledochoduodenostomy versus hepaticogastrostomy). The pooled OR (95 % CI) was 1.32 (0.51–3.38) (Cochran Q test P = 0.67, I2 = 0 %) (Fig. 9). Funnel plot was visually asymmetric, but Egger’s test failed to show publication bias (P = 0.21) (Appendix 7). Only six studies [20, 27, 35, 36, 41, 43] described post-procedure adverse
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Dig Dis Sci Table 2 Profile of adverse events with extrahepatic and intrahepatic approaches References
Park et al.a [29] Attasaranya et al. [33] Vila et al. [22]
Gupta et al. [19]
Total number of adverse events with access route where specified
Description of adverse events
EH: 5
EH: bile leak (2); mild bleeding (2); pneumoperitoneum (1);
IH: 6
IH: pneumoperitoneum (6)
Overall: 11
Bile leak (1); bleeding (1); stent slipped (1); stent deployed outside (1); perforation (1); abdominal pain (2); fever (3); retrogastric collection (1)
EH: 11
EH: bleeding (3); biloma (4), acute pancreatitis (1); cholangitis (3)
IH: 17
IH: bleeding (3); biloma (3); perforation (4); liver hematoma (2); abscess (1); acute pancreatitis (4)
EH: 29
EH: bile leak (13); bleeding (8); cholangitis (4); pneumoperitoneum (1); abdominal pain (1); stent occlusion (2) IH: bile leak (14); bleeding (18); cholangitis (4); pneumoperitoneum (11); abdominal pain (2)
IH: 52 Khashab et al.a [21]
Overall: 4
Acute cholecystitis (1); acute pancreatitis (1); pneumoperitoneum (1); sheared guide wire (1)
Kawakubo et al. [37]
EH: 7
EH: bile leak (3); bleeding (1); stent misplacement (1); pneumoperitoneum (1); perforation (1) IH: bile leak (2); bleeding (1); stent misplacement (2); cholangitis (1); biloma (1)
IH: 7 Shah et al. [31]
Overall: 6
Bile leak (1); liver hematoma (1); bacteremia (1); perforation (1); acute pancreatitis (2)
Iwashita et al. [30]
EH: 3
EH: acute pancreatitis (1); sepsis and death (1); abdominal pain (1);
IH: 1
IH: pneumoperitoneum (1)
Dhir et al.a [27]
EH: 7
EH: bile leak (3); perforation (2); cholangitis (1); stent migration (1)
IH: 2
IH: bleeding (2)
Artifon et al. [43]
EH: 3
EH: bile leak (1); bleeding (1); perforation (1),
IH: 6
IH: bleeding (3); bacteremia (1), biloma (2),
Bapaye et al. [36]
Overall: 5
Bile leak (4); death (1)
Dhir et al. [20]
EH: 4
EH: bile leak (2); perforation (1); pneumoperitoneum (1)
IH: 15 Khashab et al.a [41]
Overall: 4
IH: bile leak (2); bleeding (1); death (1); cholangitis (9); perforation (1); pneumoperitoneum (1) Pancreatitis (1); pneumoperitoneum (1); sheared guide wire (1); cholecystitis (1)
Prachayakul et al. [34]
EH: 1
EH: pneumoperitoneum (1)
IH: 1
IH: bile leak (1)
Dhir et al. [32]
EH : 1
EH: contrast leak
Takada et al. [35]
Overall: 5
Bile leak (1); bleeding (2); abdominal pain (1); early stent migration (1)
Weilert [39]
Overall: 2
Bile leak (1); abdominal pain (1)
Will et al. [38]
Overall: 7
Death (1); cholangitis (2); hemobilia (1); biloma (1); abdominal pain (2)
Song et al.a [40]
EH: 2
EH: pneumoperitoneum (1); abdominal pain (1)
IH: 3
IH: pneumoperitoneum (2); abdominal pain (1)
Dhir et al. [42]
EH: 1
EH: abdominal pain (1)
IH: 11
IH: bile leak (2); abdominal pain (7); pneumoperitoneum (2)
Most important adverse events are given in bold a
Studies using ASGE lexicon for adverse event profiling
EH extrahepatic, IH intrahepatic
events based on the method of drainage. Choledochoduodenostomy appeared significantly safer as compared to hepaticogastrostomy, and pooled OR (95 % CI) was 0.40 (0.18–0.87) (Cochran Q test P = 0.47, I2 = 0 %) (Fig. 10).
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Funnel plot appeared asymmetric, but Egger’s test did not reveal publication bias (P = 0.71) (Appendix 8). Once again, as the number of studies is less than 10 in these analyses, publication bias should be interpreted with caution.
Dig Dis Sci Fig. 2 Cumulative forest plot for the technical success of EUS-BD
Discussion The results of our meta-analysis suggest that EUS-BD is a very good alternative therapeutic modality for achieving biliary drainage in cases where ERC fails. In our analysis, the overall weighted technical success rate of EUS-BD was 90 % and the total weighted adverse event rate was 17 %. Despite having a reasonable success rate, several concerns need to be addressed before it could be widely adopted for this indication. The cumulative evidence was negatively influenced by the presence of heterogeneity among studies. Subgroup analysis based on quality of studies decreased the heterogeneity among high-quality studies; however, it continued to persist between moderate-quality studies. This difference in technical success rates and post-procedure adverse events rates is most likely driven by the fact that moderate-quality studies include data from initial experience of endoscopists with this procedure. Vila et al. [22] reported a multicenter experience of endoscopists performing EUS-BD who had performed less than 20 procedures. The technical success rate was 69 %, and the postprocedure adverse event rate was 26 %. Likewise, Will et al. [38] published a 10-year single-center experience of 94 patients with a technical success of 86.9 %. In comparison with this, more recent data from single-center [39, 40, 43] and multicenter studies [27, 37] revealed efficacy ranging from 93
to 100 % and post-procedure adverse event rates ranging from 9 to 19 %. This difference may be attributed to the learning curve associated with the procedure as shown by Attasaranya et al. [33] in a single-center study spanning over 5 years. In this study, the failure rate was 38 % in first 3 years and 11 % in last 2 years. Also the complication rate was 54 % in first 3 years as compared to 22 % in last 2 years. In the meta-regression analysis, only distal location of stricture in common bile duct and transpapillary method of drainage were associated with a higher success rate and intrahepatic route of access was associated with a higher adverse events rate. We could not perform separate analyses for efficacy and safety in malignant and benign etiologies as the reported data did not evaluate these differences, but we found that in high-quality studies 94.3 % patients had a malignant etiology as compared to 79.7 % in moderatequality studies. This could be another reason for variability in moderate-quality studies. Severity and reporting period of adverse events varied among studies. Only five studies [21, 27, 29, 40, 41] reported the adverse events utilizing the ASGE lexicon [44] and all of them were high-quality studies. These differences might also contribute toward heterogeneity. Our work could be influenced by other factors ranging from place of study, inherent differences in population in different parts of the world, types of malignancies, and types of stents used.
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Fig. 3 Forest plot for technical success based on quality of studies
Table 3 Results of meta-regression analyses for efficacy of EUS-BD Covariate
Coefficient
Distal stricture
-1.3670
0.3567
0.0001
0.3919
0.4045
0.3325
Transluminal drainage Transpapillary drainage
Standard error
P value
-1.1851
0.4084
0.0037
Extrahepatic route
0.7068
0.7726
0.3602
Intrahepatic route
-0.3612
0.8324
0.6644
Investigation of these variables would be possible only with individual patient data meta-analysis. Choosing the access route for EUS-BD is of prime importance while performing the procedure. It is evident that in certain situations such as proximal (hilar) biliary obstruction, gastrojejunostomy (e.g., Roux-en-Y), and gastric outlet obstruction the only possible access is the intrahepatic route. However, the situation in middle and distal biliary obstruction is less clear and it remains questionable as to which method has the best efficacy and safety as individual centers have individual preferences. In our meta-analysis, there was no difference in the technical success based on the approach utilized, but the extrahepatic approach appeared significantly safer as compared to the
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intrahepatic approach. The largest multicenter retrospective study failed to show any difference between the two approaches in terms of efficacy and safety [19]. Another multicenter study showed that there was no difference in efficacy of the two approaches; however, the intrahepatic approach was associated with a significantly higher rate of adverse events [20] which is in agreement with this work. Regarding the safety profile of the procedure, bile leakage was found to be the most common post-procedure adverse event in both intrahepatic and extrahepatic approach in our analysis. A problem with intrahepatic approach is that it involves needle puncture in the peritoneal cavity, which may lead to an increased risk of bile peritonitis. To address the issue of bile leakage, the question arises about the type of stent to be used. In our analysis, we could not compare the success and safety based on type of stent because data were not reported accordingly. However, bile leakage can occur both with plastic and with metallic stents. Theoretically, bile leak is less likely with covered metallic stents and they have longer patency. Kawakubo et al. [37] have compared the efficacy and safety of metallic and plastic stents in EUS-BD but did not find any difference. Although fully covered selfexpandable metallic stents (SEMS) seem more reasonable for EUS-BD, they have their own share of problems.
Dig Dis Sci Fig. 4 Cumulative forest plot for the clinical success of EUSBD
Fig. 5 Cumulative forest plot for post-procedure adverse event rates with EUS-BD
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Dig Dis Sci Fig. 6 Forest plot for postprocedure adverse events based on quality of studies
Table 4 Results of meta-regression analyses for safety of EUS-BD Covariate
Coefficient
Standard error
P value
Distal stricture
0.2969
0.2649
0.2623
Extrahepatic route
1.1424
1.4029
0.4155
Intrahepatic route
2.2363
0.7393
0.0025
Shortening after deployment can lead to stent migration, and specifically in the intrahepatic route SEMS can block adjacent intrahepatic bile ducts, leading to cholangitis. To counteract these adverse events, Song et al. [40] reported the use of a novel hybrid stent, which consists of a proximal uncovered portion and a distal covered portion with antimigration flaps. In this study, 27 patients underwent transluminal EUS-BD and none developed bile leak or stent migration. Larger trials evaluating the use of these novel accessories designed specifically for EUS-BD are required. EUS-BD Versus PTBD The technical success rate for PTBD ranges from 75 to 100 %; however, it is associated with substantial morbidity. The complication rate of PTBD ranges from 9 to 31 % [5, 46–49]. Two small studies have evaluated the efficacy and safety of EUS-BD in comparison with PTBD [41, 50].
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Artifon et al. [50] published the first randomized trial of 25 patients, comparing the efficacy and safety of choledochoduodenostomy with PTBD. The study concluded that both EUS-BD and PTBD had equal technical success, clinical success, and adverse event profile. Another retrospective study [41] failed to detect any difference in technical or clinical success. However, in this latter study the rate of unscheduled re-interventions was significantly higher for PTBD as compared to EUS-BD (45.1 vs 15.8 %, P = 0.02). Also, when considering all subsequent re-interventions, the rate of adverse events was significantly higher in patients undergoing PTBD. Multicenter large randomized controlled trials are required in this regard to prove which modality is better for achieving satisfactory biliary drainage. Strengths and Limitations of Our Analysis This is the first meta-analysis evaluating the cumulative efficacy and safety of EUS-BD. Our rigorously conducted analysis involves a comprehensive literature search with inclusion of the largest number of relevant studies and adds substantially to the cumulative evidence. We excluded small case series to minimize the inherent bias associated with them. We also examined the efficacy and safety of the two approaches utilized for EUS-BD. The results of our analysis are weakened by limitations inherent to meta-
Dig Dis Sci Fig. 7 Forest plot to compare the technical success of extrahepatic versus intrahepatic approach in distal biliary strictures
Fig. 8 Forest plot to compare post-procedure adverse event rates of extrahepatic versus intrahepatic approach in distal biliary strictures
analysis and those of the included studies. The included studies differed in etiologies for biliary obstruction, methods for creation and dilatation of bilioenteric fistula, types of stents, reporting of adverse events, and methods of biliary drainage. All these factors may have had an influence on the pooled effect estimate which may be considered as a weakness in our analysis.
Currently, three randomized controlled trials are recruiting patients to compare the efficacy and safety of PTBD and EUS-BD. As of now EUS-BD is limited to tertiary care hospitals with advanced-complex endoscopy units. However, consortium meetings [52, 53] are held every year to discuss the progress achieved in the refining of this procedure and hands-on workshops are being organized to train the next-generation endoscopists [54].
Future Directions EUS-BD is a technique destined to grow. One major development would be to make a single-step device specific for EUS-BD, which would help endoscopists to overcome the cumbersome phases such as multiple guidewire exchanges and would make the procedure safer and shorter. A novel exchange free technique has been recently described for creation of choledochoduodenostomy [51].
Conclusion Our findings suggest that EUS-BD appears to be an emerging therapeutic option for biliary decompression in cases where ERC fails. The cumulative efficacy of EUSBD was 90 % and the cumulative adverse event rate was 17 %. Randomized controlled trials evaluating the efficacy
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Dig Dis Sci Fig. 9 Forest plot comparing technical success of choledochoduodenostomy versus hepaticogastrostomy in distal biliary strictures
Fig. 10 Forest plot comparing the post-procedure adverse events with choledochoduodenostomy versus hepaticogastrostomy in distal biliary strictures
of this procedure in comparison with other therapeutic modalities are required. Acknowledgments We are grateful to Dr. Michel Kahaleh, Dr. Juan Vila, Dr. Amol Bapaye, Dr. Frank Weilert, and Dr. Vinay Dhir for providing information and unpublished data from their studies. We thank Dr. Colin W. Howden for his critical review of the manuscript. Author contribution Muhammad Ali Khan was involved in conception and design; analyzed and interpreted the data; drafted and finally approved the article, Ali Akbar was involved in conception and design; analyzed the data; finally approved the article, Todd H Baron was involved in conception and design; drafting of article; critical revision for intellectual content and final approval of article, Sobia Khan contributed to statistical analysis, Mehmat Kocak contributed to statistical analysis and finally approved the article, Yaseen Alastal was involved in data collection; analyzed; and finally approved the article, Tariq Hammad was involved in data collection and finally approved the article, Wade M Lee was involved in search strategy and data collection, Aijaz Sofi contributed to statistical analysis, Everson L. A. Artifon
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and Ali Nawras was involved in critical revision for intellectual content and final approval of article, Mohammad Kashif Ismail contributed to conception and design; analysis and interpretation of data; drafting of article; critical revision; and final approval of article. Compliance with ethical standards Conflict of interest Dr. Todd H Baron (T.H.B) is a consultant for Xlumena, ConMed, WL Gore, BSCI, Cook, Olympus and receive honoraria for speaking from all of them, he does not have stock or receive royalties from any of the companies. Dr. Everson L A Artifon (E.L.A) Artifon is a speaker for mediglobe. He does not have stocks or receive royalty from the company. None of the other authors have any financial disclosures or conflicts of interest to declare.
Appendix 1 See Fig. 11.
Dig Dis Sci Fig. 11 Quality assessment tables
Table 1S: Methodological quality assessment of cohort studies based on the Newcastle-Oawa Scale Study Selecon Comparability Park, 2011 3 2 Aasaranya, 2012 2 1 Vila, 2012 3 1 Gupta, 2012 2 2 Khashab, 2013 3 2 Shah, 2011 2 1 Iwashita, 2011 2 2 Dhir, 2014 3 2 Bapaye, 2013 3 2 Dhir, 2013 3 1 Khashab, 2014 3 2 Prachayakul, 2013 3 2 Dhir, 2012 3 2 Takada, 2013 3 2 Weilert, 2014 3 2 Will, 2014 3 2 Song, 2014 3 2 Dhir, 2013 3 2 Quality assessment of randomized trial based on Jadad scale Study Randomizaon Blinding Arfon, 2014
2
0
Outcome 3 2 2 2 3 2 2 3 1 2 3 3 2 2 3 2 3 2
Total 8 5 6 6 8 5 6 8 6 6 8 8 7 7 8 7 8 7
Account of all paents 1
3
Appendix 2 See Fig. 12. Fig. 12 Funnel plot for technical success of EUS-BD
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Appendix 3 See Fig. 13.
Fig. 13 Funnel plot for clinical success of EUS-BD
Appendix 4 See Fig. 14.
Fig. 14 Funnel plot for postprocedure adverse event rates of EUS-BD
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Appendix 5 See Fig. 15.
Fig. 15 Funnel plot for comparing the technical success of extrahepatic versus intrahepatic approach in distal biliary strictures
Appendix 6 See Fig. 16.
Fig. 16 Funnel plot for comparing the post-procedure adverse event rates of extrahepatic versus intrahepatic approach in distal biliary strictures
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Appendix 7 See Fig. 17.
Fig. 17 Funnel plot for comparing technical success of choledochoduodenostomy versus hepaticogastrostomy in distal biliary strictures
Appendix 8 See Fig. 18.
Fig. 18 Funnel plot for comparing the post-procedure adverse events with choledochoduodenostomy versus hepaticogastrostomy in distal biliary strictures
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References 1. Varadarajulu S, Kilgore ML, Wilcox CM, Eloubeidi MA. Relationship among hospital ERCP volume, length of stay, and technical outcomes. Gastrointest Endosc. 2006;64:338–347. 2. Ang TL, Teo EK, Fock KM. EUS-guided transduodenal biliary drainage in unresectable pancreatic cancer with obstructive jaundice. JOP. 2007;8:438–443. 3. Burmester E, Niehaus J, Leineweber T, Huetteroth T. EUScholangio-drainage of the bile duct: report of 4 cases. Gastrointest Endosc. 2003;57:246–251. 4. Puspok A, Lomoschitz F, Dejaco C, Hejna M, Sautner T, Gangl A. Endoscopic ultrasound guided therapy of benign and malignant biliary obstruction: a case series. Am J Gastroenterol. 2005;100:1743–1747. 5. Beissert M, Wittenberg G, Sandstede J, et al. Metallic stents and plastic endoprostheses in percutaneous treatment of biliary obstruction. Z Gastroenterol. 2002;40:503–510. 6. Winick AB, Waybill PN, Venbrux AC. Complications of percutaneous transhepatic biliary interventions. Techn Vasc Interv Radiol. 2001;4:200–206. 7. Oh HC, Lee SK, Lee TY, et al. Analysis of percutaneous transhepatic cholangioscopy-related complications and the risk factors for those complications. Endoscopy. 2007;39:731–736. 8. Giovannini M, Moutardier V, Pesenti C, Bories E, Lelong B, Delpero JR. Endoscopic ultrasound-guided bilioduodenal anastomosis: a new technique for biliary drainage. Endoscopy. 2001;33:898–900. 9. Artifon EL, Ferreira FC, Otoch JP, Rasslan S, Itoi T, PerezMiranda M. EUS-guided biliary drainage: a review article. JOP. 2012;13:7–17. 10. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700. 11. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000;283:2008–2012. 12. Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, Einarson TR. Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association. CMAJ Can Med Assoc J (journal de l’Association medicale canadienne). 1994;150:1611–1615. 13. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev. 2007;2:MR000005. 14. Sterne JA, Gavaghan D, Egger M. Publication and related bias in meta-analysis: power of statistical tests and prevalence in the literature. J Clin Epidemiol. 2000;53:1119–1129. 15. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177–188. 16. Deeks JH, Altman, D. Chapter 9: Analysing data and undertaking meta-analyses. In: Cochrane handbook for systematic reviews of interventions, Version 5.0.1 [updated September 2008]. The Cochrane Collaboration; 2008. 17. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics.. 1994;50:1088–1101. 18. Kelley GA, Kelley KS. Statistical models for meta-analysis: a brief tutorial. World J Methodol. 2012;2:27–32. 19. Gupta K, Perez-Miranda M, Kahaleh M, et al. Endoscopic ultrasound-assisted bile duct access and drainage: multicenter, long-term analysis of approach, outcomes, and complications of a technique in evolution. J Clin Gastroenterol. 2014;48:80–87.
20. Dhir V, Artifon EL, Gupta K, et al. Multicenter study on endoscopic ultrasound-guided expandable biliary metal stent placement: choice of access route, direction of stent insertion, and drainage route. Dig Endosc. 2014;26:430–435. 21. Khashab MA, Valeshabad AK, Modayil R, et al. EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos). Gastrointest Endosc. 2013;78:734–741. 22. Vila JJ, Perez-Miranda M, Vazquez-Sequeiros E, et al. Initial experience with EUS-guided cholangiopancreatography for biliary and pancreatic duct drainage: a Spanish national survey. Gastrointest Endosc. 2012;76:1133–1141. 23. Wells GS, Shea B, O’ Connell D, et al. The Newcastle-Ottawa scale (NOS) for assessing the quality of nonrandomized studies in meta-analyses. http://www.ohrica/programs/clinical_epidemiol ogy/oxford.asp. Accessed 1 June 2015. 24. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12. 25. Maranki J, Hernandez AJ, Arslan B, et al. Interventional endoscopic ultrasound-guided cholangiography: long-term experience of an emerging alternative to percutaneous transhepatic cholangiography. Endoscopy.. 2009;41:532–538. 26. Kahaleh M, Hernandez AJ, Tokar J, Adams RB, Shami VM, Yeaton P. Interventional EUS-guided cholangiography: evaluation of a technique in evolution. Gastrointest Endosc. 2006; 64:52–59. 27. Dhir V, Itoi T, Khashab MA, et al. Multicenter comparative evaluation of endoscopic placement of expandable metal stents for malignant distal common bile duct obstruction by ERCP or EUS-guided approach. Gastrointest Endosc. 2015;81:913–923. 28. Park do H, Jeong SU, Lee BU, et al. Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video). Gastrointest Endoscopy. 2013;78:91–101. 29. Park do H, Jang JW, Lee SS, Seo DW, Lee SK, Kim MH. EUSguided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results. Gastrointest Endosc. 2011;74:1276–1284. 30. Iwashita T, Lee JG, Shinoura S, et al. Endoscopic ultrasoundguided rendezvous for biliary access after failed cannulation. Endoscopy.. 2012;44:60–65. 31. Shah JN, Marson F, Weilert F, et al. Single-operator, singlesession EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla. Gastrointest Endosc. 2012; 75:56–64. 32. Dhir V, Bhandari S, Bapat M, Maydeo A. Comparison of EUSguided rendezvous and precut papillotomy techniques for biliary access (with videos). Gastrointest Endosc. 2012;75:354–359. 33. Attasaranya S, Netinasunton N, Jongboonyanuparp T, et al. The spectrum of endoscopic ultrasound intervention in biliary diseases: a single center’s experience in 31 cases. Gastroenterol Res Pract. 2012;2012:680753. 34. Prachayakul V, Aswakul P. A novel technique for endoscopic ultrasound-guided biliary drainage. WJG World J Gastroenterol. 2013;19:4758–4763. 35. Takada J, Carmo AM, Artifon EL. EUS-guided biliary drainage for malignant biliary obstruction in patients with failed ERCP. J Interv Gastroenterol. 2013;3:76–81. 36. Bapaye A, Dubale N, Aher A. Comparison of endosonographyguided vs. percutaneous biliary stenting when papilla is inaccessible for ERCP. United European Gastroenterol J. 2013;1:285–293. 37. Kawakubo K, Isayama H, Kato H, et al. Multicenter retrospective study of endoscopic ultrasound-guided biliary drainage for
123
Dig Dis Sci
38.
39.
40.
41.
42.
43.
44.
45.
46.
malignant biliary obstruction in Japan. J Hepato Biliary Pancreat Sci. 2014;21:328–334. Will U, Fueldner F, Kern C, Meyer F. EUS-Guided Bile Duct Drainage (EUBD) in 95 Patients. Ultraschall in der Medizin. 2015;36:276–283. Weilert F. Prospective evaluation of simplified algorithm for EUS-guided intra-hepatic biliary access and anterograde interventions for failed ERCP. Surg Endosc. 2014;28:3193–3199. Song TJ, Lee SS, Park do H, Seo DW, Lee SK, Kim MH. Preliminary report on a new hybrid metal stent for EUS-guided biliary drainage (with videos). Gastrointestinal endoscopy. 2014;80:707–711. Khashab MA, Valeshabad AK, Afghani E, et al. A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Dig Dis Sci. 2015;60:557–565. Dhir V, Bhandari S, Bapat M, Joshi N, Vivekanandarajah S, Maydeo A. Comparison of transhepatic and extrahepatic routes for EUS-guided rendezvous procedure for distal CBD obstruction. United Eur Gastroenterol J. 2013;1:103–108. Artifon EL, Marson FP, Gaidhane M, Kahaleh M, Otoch JP. Hepaticogastrostomy or choledochoduodenostomy for distal malignant biliary obstruction after failed ERCP: Is there any difference? Gastrointest Endosc. 2015;81:950–959. Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010;71:446–454. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991;37:383–393. Stanley J, Gobien RP, Cunningham J, Andriole J. Biliary decompression: an institutional comparison of percutaneous and endoscopic methods. Radiology. 1986;158:195–197.
123
47. Garcarek J, Kurcz J, Guzinski M, Janczak D, Sasiadek M. Ten years single center experience in percutaneous transhepatic decompression of biliary tree in patients with malignant obstructive jaundice. Adv Clin Exp Med. 2012;21:621–632. 48. Kuhn JP, Busemann A, Lerch MM, Heidecke CD, Hosten N, Puls R. Percutaneous biliary drainage in patients with nondilated intrahepatic bile ducts compared with patients with dilated intrahepatic bile ducts. AJR Am J Roentgenol. 2010;195:851–857. 49. Doctor N, Dick R, Rai R, et al. Results of percutaneous plastic stents for malignant distal biliary obstruction following failed endoscopic stent insertion and comparison with current literature on expandable metallic stents. Eur J Gastroenterol Hepatol. 1999;11:775–780. 50. Artifon EL, Aparicio D, Paione JB, et al. Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage. J Clin Gastroenterol. 2012; 46:768–774. 51. Tarantino I, Barresi L, Granata A, Ligresti D, Curcio G, Traina M. Single-step EUS-guided choledocoduodenostomy and stenting. Gastrointest Endosc. 2015;81:1016–1017. 52. Kahaleh M, Artifon EL, Perez-Miranda M, et al. Endoscopic ultrasonography guided biliary drainage: summary of consortium meeting, May 7th, 2011, Chicago. World J Gastroenterol WJG. 2013;19:1372–1379. 53. Kahaleh M, Artifon E, Perez-Miranda M, et al. Endoscopic ultrasonography guided drainage: summary of consortium meeting, May 21, 2012, San Diego, California. World J Gastroenterol WJG.. 2015;21:726–741. 54. Dhir V, Itoi T, Fockens P, et al. Novel ex vivo model for hands-on teaching of and training in EUS-guided biliary drainage: creation of ‘‘Mumbai EUS’’ stereolithography/3D printing bile duct prototype (with videos). Gastrointest Endosc. 2015;81:440–446.
