Transjugular Insertion of Bare-Metal Biliary Stent for

Cardiovasc Intervent Radiol DOI 10.1007/s00270-012-0453-6

TECHNICAL NOTE

Transjugular Insertion of Bare-Metal Biliary Stent for the Treatment of Distal Malignant Obstructive Jaundice Complicated by Coagulopathy Jiaywei Tsauo • Xiao Li • Hongcui Li • Bo Wei • Xuefeng Luo • Chunle Zhang Chengwei Tang • Weiping Wang

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Received: 18 April 2012 / Accepted: 12 July 2012 Ó Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2012

Abstract Purpose This study was designed to investigate retrospectively the feasibility of transjugular insertion of biliary stent (TIBS) for the treatment of distal malignant obstructive jaundice complicated by coagulopathy. Methods Between April 2005 and May 2010, six patients with distal malignant obstructive jaundice associated with coagulopathy that was unable to be corrected underwent TIBS at our institution for the palliation of jaundice. Patients’ medical record and imaging results were reviewed to obtain information about demographics, procedure details, complications, and clinical outcomes.

J. Tsauo X. Li (&) H. Li B. Wei X. Luo C. Zhang C. Tang Department of Gastroenterology and Hepatology, West China Hospital of Sichuan University, Chengdu 610041, People’s Republic of China e-mail: [email protected] J. Tsauo e-mail: [email protected] H. Li e-mail: [email protected]

Results The intrahepatic biliary tract was successfully accessed in all six patients via transjugular approach. The procedure was technically successfully in five of six patients, with a bare-metal stent implanted after traversing the biliary strictures. One procedure failed, because the guidewire could not traverse the biliary occlusion. One week after TIBS, the mean serum bilirubin in the five successful cases had decreased from 313 lmol/L (range 203.4–369.3) to 146.2 lmol/L (range 95.8–223.3) and had further decreased to 103.6 lmol/L (range 29.5–240.9) at 1 month after the procedure. No bleeding, sepsis, or other major complications were observed after the procedure. The mean survival of these five patients was 4.5 months (range 1.9–5.8). On imaging follow-up, there was no evidence of stent stenosis or migration, with 100 % primary patency. Conclusions When the risks of hemorrhage from percutaneous transhepatic cholangiodrainage are high, TIBS may be an effective alternative for the treatment of distal malignant obstructive jaundice. Keywords Non-vascular interventions Venous intervention Bile duct/gallbladder/biliary

B. Wei e-mail: [email protected] X. Luo e-mail: [email protected]

Introduction

C. Zhang e-mail: [email protected]

Malignant obstructive jaundice is commonly associated with a poor prognosis. This condition is caused most often by pancreatic carcinoma, cholangiocarcinoma, gallbladder carcinoma, metastatic tumor, and periampullary tumors. Because most patients with this condition are unable to undergo a curative resection, palliative treatment involving insertion of a biliary stent can improve both quality of life and survival [1].

C. Tang e-mail: [email protected] W. Wang Section of Interventional Radiology, Cleveland Clinic, Imaging Institute, 9500 Euclid Avenue, Cleveland, OH 44195, USA e-mail: [email protected]

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J. Tsauo et al.: Transjugular insertion of bare-metal biliary stent

Depending on the patient’s personal preferences, life expectancy, and the level of obstruction, an internal biliary stent may be implanted through endoscopic retrograde cholangiopancreatogram (ERCP) or percutaneous transhepatic cholangiodrainage (PTCD) [2]. When stent insertion through ERCP is unsuccessful, PTCD is the only minimally invasive option available in most practices. The reported technical success rate for stent insertion through PTCD varied in different studies but is generally reported to be more than 90 % [3]. Overall, PTCD is a safe procedure, but it is associated with bleeding complications primarily related to transhepatic access [4]. The reported rate of bleeding complications for PTCD is 2.5 % [5], and in the presence of coagulopathy, the risk of bleeding complications increases [5]. For this reason, PTCD is generally contraindicated when a patient has uncorrected coagulopathy [5]. Two case reports have described the use of transjugular insertion of bare-metal biliary stent (TIBS) as an alternative to PTCD for the palliative treatment of malignant biliary duct obstruction associated with ascites and coagulopathy [6, 7], but this procedure has not been commonly performed because of its technical difficulty. In this study, we retrospectively reviewed our case series of patients treated with TIBS to investigate the feasibility of this technique in patients with malignant obstructive jaundice and uncorrectable coagulopathy.

Materials and Methods Study Design This study was approved by our institutional review board. A retrospective review of TIBS for the treatment of unresectable malignant obstruction was performed, with cases identified through the departmental procedure log. Patients’ medical records were reviewed and data were collected, including information about demographics, procedure details, complications, and clinical outcomes. All available

images were retrieved, and factors that affected the TIBS procedure were analyzed. Technical success of TIBS was defined as the successful placement of stent or stents in the biliary stricture or strictures. Anatomic success was defined as the restoration of bile flow confirmed by cholangiography at the time of the procedure. A complication was defined as any undesired result of the TIBS procedure and was classified according to the Society of Interventional Radiology classification system [5]. Primary patency was defined as the interval between the time of stent implantation and the time at which in-stent restenosis was diagnosed. Patients From April 2005 to May 2011, six patients with unresectable malignant obstructive jaundice underwent TIBS at our department (Table 1), including two men and four women with a mean age of 65.8 years (range 51–83). Two patients had pancreatic cancer, two had cholangiocarcinoma, one had gallbladder cancer, and one had rectal cancer. All of the patients had a failed ERCP because of distal bile duct obstruction. All patients were withheld from PTCD, because they had an International normalized ratio (INR) of 2.0 or more, which is considered to be the absolute limit for a safe transhepatic procedure at out institution. The patients underwent attempted correction of coagulopathy (vitamin K and plasma infusion) without a significant reduction in INR. Consequently, TIBS was proposed and consensus was obtained after discussions with patients and referring physicians. Imaging and clinical follow-up was performed on a monthly basis after the procedure until death. TIBS Technique All procedures were performed by a single operator who had performed more than 500 transjugular intrahepatic portosystemic shunt (TIPS) procedures. Patients received a prophylactic antibiotic (oral ciprofloxacin 750 mg) 30 min

Table 1 Summary of patient data Patient/age (year)/sex

Malignancy

Prothrombin time (s)

International normalized ratio

Size of stent implanted

Bilirubin (lmol/L)

Survival (month)

Before TIBS

Week after TIBS

Month after TIBS

1/51/F 2/66/F

Pancreatic cancer Cholangiocarcinoma

19.4 27.1

2.13 3.07

10 mm 9 80 mm 10 mm 9 80 mm

203.4 291.6

95.8 270.3

29.5 240.9

4.9 1.9

3/66/M

Rectal cancer

24.8

2.79

10 mm 9 80 mm

365.6

152.0

92.6

5.6

4/63/F

Pancreatic cancer

21.5

2.41

10 mm 9 80 mm

369.3

145.3

72.1

5.8

5/50/M

Cholangiocarcinoma

22.4

2.64

_

319.4

_

_

6/83/F

Gallbladder cancer

24.3

2.86

10 mm 9 60 mm

335.1

114.6

80.2

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_ 4.3


before the TIBS procedure. The procedure was performed under intravenous conscious sedation (induced with midazolam 1 mg and fentanyl 1 lg/Kg). Available preprocedure images were reviewed in each case to determine the extent of disease and for anatomy, and the RoschUchida transjugular liver access set (Cook Incorporated, Bloomington, IN) was manually shaped accordingly. After sterile preparation, the right internal jugular vein was accessed, and the transjugular liver access set was introduced into the right or mid hepatic vein. The puncture needle was advanced toward the region of the intrahepatic bile duct under fluoroscopy. The needle was withdrawn, and when bile was freely aspirated, a small amount of contrast was hand injected to confirm needle position. Once access in a relatively peripheral intrahepatic duct was

confirmed, a guidewire was introduced into the biliary tract, and the 10-Fr, 30-cm-long sheath was introduced into the bile duct. The guidewire was advanced across the obstructed biliary segment and into the duodenum. The stricture was dilated with an 80 9 60-mm balloon (POWERFLEXTM, Cordis, LJ Roden, Netherlands) (Figs. 1A, 2A). A bare-metal self-expanding stent (S.M.A. R.T.Ò CONTROLÒ, Cordis Corporation, Miami, FL) with specifications selected according to the diameter of the adjacent biliary duct was deployed across the stricture (Table 1; Figs. 1B, 2B). After successful stent placement, a completion cholangiogram was performed to confirm stent patency and restoration of biliary flow (Figs. 1C, 2C). When required, the stent was dilated with the balloon catheter. The intrahepatic tract was then embolized with

Fig. 1 Gallbladder cancer causing distal biliary obstruction in an 83-year-old woman (patient 6). A Balloon dilation of the extrahepatic biliary stricture with an 80 9 60-mm angioplasty balloon catheter. B Successful placement of a 10 9 60-mm bare metal stent across the

extrahepatic biliary stricture. C Final cholangiography showing contrast entering the duodenum and the alleviation of intrahepatic ductal dilation, suggesting restoration of biliary flow and decompression of the biliary tree

Fig. 2 Pancreatic cancer causing distal biliary obstruction in a 51-year-old woman (patient 1). A Balloon dilation of the extrahepatic biliary stricture with an 80 9 60-mm angioplasty balloon catheter. B Successful placement of a 10 9 80-mm bare metal stent across the

extrahepatic biliary stricture. C Final cholangiography showing contrast passing through the stent and entering the duodenum, suggesting restoration of biliary flow

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Gelfoam slurry while the sheath was retracted from the bile duct. The transjugular sheath was removed, and access-site hemostasis was obtained with manual compression. The patient was then transferred to the recovery room for monitoring. An antibiotic (intravenous infusion of ciprofloxacin 400 mg/8 h) was administered for 3 days after the procedure.

Discussion

The intrahepatic biliary tract was successfully accessed in all six patients via the transjugular approach. Cholangiography revealed marked intrahepatic ductal dilations with extrahepatic bile duct occlusion in all six patients. The guidewire was successfully advanced across the biliary stricture in five patients, and balloon dilatation with bare-metal stent insertion was successful in each of these cases. In each of the successful cases, only a single stent was required. In one case, the guidewire would not cross the biliary occlusion; therefore, no stent was implanted. The subsequent results exclude this unsuccessful case. One week after the procedure, the average serum bilirubin had decreased from 313 lmol/L (range 203.4–369.3) to 146.2 lmol/L (range 95.8–223.3) and had further decreased to 103.6 lmol/L (range 29.5–240.9) at 1 month after TIBS (Table 1; Fig. 3). No procedure-related bleeding or sepsis was observed, including in the unsuccessful case. Two patients complained of abdominal pain that lasted for a few hours immediately after the procedure; these patients were treated with nonsteroidal anti-inflammatory agents (celecoxib 200 mg), with pains resolving within 12 h. Imaging follow-up demonstrated no evidence of stent stenosis or migration, with primary patency of 100 %. All five patients who underwent successful TIBS subsequently died as a result of the underlying primary disease, with a mean survival of 4.5 months (range 1.9–5.8).

In 1970, Hanafee et al. [8] described two cases of balloon dilation via the transjugular route for the treatment of anastomotic biliary stenoses. Although no stent was deployed, the investigators demonstrated the feasibility of performing biliary interventions through a transjugular approach in this study. Biliary stenting through the transjugular route was first described by Ring et al. [6] in 1991 for a patient with distal biliary obstruction complicated by severe ascites. In 1996, Amygdalos et al. [7] reported a case of biliary stenting and a case of biliary stent revision using the same approach in patients with severe coagulopathy and moderate ascites. Abnormal coagulation status often is seen in patients with malignant obstructive jaundice and is frequently the result of multiple factors, such as vitamin K deficiency, primary malignancy, chemotherapy, underlying liver diseases, or systemic inflammation—all of which can be difficult to treat [9]. In patients with uncorrected coagulopathy, the hemorrhagic risks of PTCD are increased [5]. Technically, compared with PTCD, biliary stent placement through the transjugular approach has an advantage in that it does not violate the liver capsule, which theoretically reduces the risk of bleeding in the peritoneum. If bleeding does occur, the blood may move back into the venous system, so no actual blood loss will result. For this reason, the TIBS procedure may be an attractive option for patients with severe coagulopathy, especially for physicians who are comfortable performing the TIPS procedure. According to the literature, the risk of bleeding complications from transjugular liver biopsy (TJLB) is similar to the risk from percutaneous liver biopsy [10], despite the fact that patients who underwent TJLB frequently had severe coagulopathy. These results suggest that TJLB is generally safer than percutaneous liver biopsy. TIBS also may be an effective option for the treatment of extrahepatic malignant obstructive jaundice complicated

Fig. 3 Pancreatic cancer causing distal biliary obstruction in a 51-year-old woman (patient 1). A Preprocedure contrast-enhanced computed tomography showing markedly dilated intrahepatic biliary

tree. B Postprocedure contrast-enhanced computed tomography at 1 week after procedure showing alleviation of intrahepatic ductal dilation

Results

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by ascites [6]. Many practitioners consider ascites to be contraindication to a percutaneous biliary drain [11], because ascites can create a gap between the abdominal wall and the liver, allowing the catheter to buckle within the peritoneal cavity. Moreover, bile leak along the parenchymal track may increase the risk of peritonitis, and ascites leak from the skin entry site may complicate nursing care and fluid management. The actual puncture is the most technically difficult part of the TIBS procedure. However, through careful assessment of preprocedure computed tomography scans and/or magnetic resonance cholangiopancreatography, the operator may learn the position of the intrahepatic ducts and their position relative to hepatic veins. Furthermore, most patients with distal malignant obstructive jaundice have significantly dilated ducts, and the transjugular needle may be manually shaped to increase the accuracy of needle puncture. Doppler ultrasound or an ultrasound probe from the femoral arterial access also may be able to reveal the position of the intrahepatic ducts, arteries, and veins. This may be helpful during the puncture process, especially in patients with nondilated biliary ducts. Compared with PTCD, one disadvantage of the TIBS procedure is that it does not allow for the placement of a decompressing external biliary drainage catheter if required after stent placement. TIBS may increase the risk of sepsis, because infected bile could potentially reflux into the venous system through the intrahepatic channel. In addition, because procedural equipment is being passed into the biliary tract and duodenum, these devices may become contaminated and further contribute to blood infections when they are retrieved. Therefore, we suggest that patients who show signs of cholangitis should not undergo the TIBS procedure. Furthermore, to avoid sepsis, we recommend the following steps: (1) use antibiotics before and after the procedure; (2) after gaining access to the biliary duct, immediately set the 10-Fr, 30-cm outer sheath in the bile duct to isolate bile and contaminated equipment from the venous blood; (3) remove an adequate amount of bile decompressing the biliary tree to prevent retrograde flow during stent operations; and (4) embolize the intrahepatic channel with Gelfoam at the end of the procedure to prevent retrograde flow. The use of these protocols may account for why none of the patients in

our study experienced procedure-related infections. Heightened awareness is warranted because sepsis has a high risk of mortality. In conclusion, when the hemorrhagic risks of PTCD are high, TIBS may be an effective alternative for the treatment of distal malignant obstructive jaundice. Acknowledgment We thank Chinese Interventional Radiology Club (CIR Club) for the manuscript preparation. This paper is supported by the Natural Science Fund of China (Grant No. 30770984 and 81171444). Conflict of interests The authors declare that they have no conflict of interests.

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