OBES SURG (2013) 23:687–692 DOI 10.1007/s11695-012-0861-3
ORIGINAL CONTRIBUTIONS
Gastric Leak After Laparoscopic Sleeve Gastrectomy: Early Covered Self-Expandable Stent Reduces Healing Time F. Simon & I. Siciliano & A. Gillet & B. Castel & B. Coffin & S. Msika
Published online: 12 January 2013 # Springer Science+Business Media New York 2013
Abstract Background Laparoscopic sleeve gastrectomy has become a very frequent procedure in bariatric surgery due to its efficacy and simplicity compared to gastric bypass. Gastric staple line leak (1 to 7 % of cases) is a severe complication with a long nonstandardized treatment. The aim of this retrospective study was to examine the success and tolerance of covered stents in its management. Methods From January 2009 to December 2011, nine patients with gastric staple line leaks after sleeve gastrectomy were treated with covered stents in our department (seven referred from other institutions). The leaks were diagnosed by CT scan and visualized during the endoscopy. Among the studied variables were operative technique, postoperative fistula diagnosis delay, stent treatment delay, and stent tolerance. In our institution, Hanarostent® (length 17 cm, diameter 18 mm; M.I. Tech, Seoul, Korea) was used and inserted under direct endoscopic control. Results Stent treatment was successful in seven cases (78 %). Two other cases had total gastrectomy (405 and 185 days after
F. Simon : I. Siciliano : B. Castel : S. Msika (*) Paris Nord Obesity Referral Center, Department of Digestive Surgery, Hôpital Louis-Mourier (Assistance Publique des Hôpitaux de Paris), Université Paris 7 Denis-Diderot, 178 rue des Renouillers, 92700 Colombes, France e-mail:
[email protected] A. Gillet : B. Coffin Paris Nord Obesity Referral Center, Department of Hepato-gastro-enterology, Hôpital Louis-Mourier (Assistance Publique des Hôpitaux de Paris), Université Paris 7 Denis-Diderot, Colombes, France
leak diagnosis). Early stent removal (due to migration or poor tolerance) was necessary in three cases. The average stent treatment duration was of 6.4 weeks, and the average healing time was 141 days. The five patients with an early stent treatment (≤3 weeks after leak diagnosis) had an average healing time of 99 days versus 224 for the four others. Conclusions Covered self-expandable stent is an effective treatment of gastric leaks after sleeve gastrectomy. Early stent treatment seems to be associated with shorter healing time. Keywords Laparoscopic sleeve gastrectomy . Bariatric surgery . Obesity . Gastric leak . Covered stent
Introduction Laparoscopic sleeve gastrectomy (LSG) has become a very frequent procedure in bariatric surgery, due to its simplicity and efficacy compared to the gastric bypass procedure [1–3]. In France, 9,862 LSGs were carried out in 2010 versus 1,315 in 2007 [4]. Many studies have shown an effective excess weight loss (EWL) 1 year from the procedure, from 50 to 67 % EWL, and from 66 to 72 % EWL after 3 years [5–7]. Weight loss mechanisms are both restrictive and hormonal, and post-LSG diabetes improvement has been observed [8–12]. There are two life-threatening complications: bleeding and gastric staple line leak. Different studies show that post-sleeve gastric leaks occur in 0.6 to 7 % of cases [6, 12–18]. It is a severe complication which can take many weeks to heal due to the difficulty of the treatment [3, 13, 19, 20]. There is no standardized management: methods vary from reoperation to radiologic or
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percutaneous drainage, endoscopic procedures (covered self-expandable stents or drainage), fibrin glue, or sole medical treatment [3, 13, 20–27]. Few studies have specifically studied the effectiveness of post-LSG gastric leak treatment with covered stents [17, 19, 28, 29]. The aim of this study was to examine the success and tolerance of covered stents in the management of gastric leaks after sleeve gastrectomy and discuss the best strategy.
Patients and Methods Patients From January 2009 to December 2011, nine patients who underwent LSG were treated for staple line leaks in our department (Paris Nord Bariatric Referral Center) using endoscopic covered stents (two LSGs from our institution and seven were referred to us from other institutions). All patients treated by stents during this period were included in this study. In our department, from 2006 to 2011, a total of 53 patients have undergone sleeve gastrectomy leading to three staple line leaks (5.6 %). One patient was successfully treated medically without stent or drainage due to the absence of fluid collections on the CT scan and was not included in this study. The results were reviewed retrospectively. All the leaks were diagnosed by CT scan and visualized during the endoscopic procedure. Although some patients received a first unsuccessful treatment in other institutions, all were eventually treated with endoscopic covered stents in our department. The following variables were studied: gender, age, body mass index (BMI), comorbidities, complications during surgery, use of reinforcement sutures along the staple line, sleeve calibration, time to leak diagnosis, leak symptoms, and leak diagnosis methods and results. Concerning the treatment, we observed time to first treatment (surgery and endoscopy), duration of stent treatment, need for ICU, nutrition (enteral and/or parenteral), stent tolerance, stent migration, stent replacement, time to second treatment if necessary, total leak duration, and final exam confirming the healing. Endoscopic Procedure Hanarostent® (M.I. Tech, Seoul, Korea) was systematically used in our institution for its specific features. These stents have an anti-reflux valve to prevent gastroesophageal reflux and are covered in silicone to prevent tissue ingrowth. They also have a segmented body and larger head bands to minimize the risk of migration and a repositioning lasso to facilitate repositioning of mislocated stents. The endoscopic procedure was systematically conducted in the same way:
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the fistula was first visualized and its distance to the dental arches was measured. It was then catheterized and opacified to explore the cavities and collections. A 17-cm-long esophageal covered stent (Hanarostent®, diameter 18 mm) was inserted under direct endoscopic control and positioned to ensure that the proximal pole of the stent was 5 to 7 cm above the fistula. The stent was then fixed using clips on the proximal pole, and a final opacification was done to ensure that the stent was effective. When possible, a feeding tube was positioned in the distal duodenum for enteral nutrition. The stents were to be removed endoscopically 4 to 6 weeks later, if complete healing was observed. If the fistula persisted, the stent treatment was prolonged with a new stent being inserted during the same endoscopic procedure. Endoscopic procedures performed in other institutions were not specified.
Results Nine patients were treated in our institution for gastric leaks after sleeve gastrectomy. Patient characteristics and their global treatment are presented in Table 1. There were eight females and one male, whose mean age is 42 years (range 25 to 65) and whose mean BMI is 44.1 kg/m2 (range 37 to 55). Seven patients presented the following comorbidities, mostly secondary to their obesity: gonalgia, back pain, diabetes type 2, or hypertension. No patients had prior bariatric surgery, especially gastric banding. LSG and leak characteristics are presented in Table 2. Three of the initial sleeve gastrectomy procedures encountered intraoperative difficulties including a defective stapler (one case), staple line bleeding (one case), and intraoperative blue test leak (one case). The average caliber used for the sleeve construction was 34 Fr (range 26 to 36). Staple use was not standardized (as patients were operated on in different institutions): staple height varied from 3.5 to 4.8 mm. In six cases, sutures were used in addition to the staple line, either stitches at staple intersections or continuous running suture. Leak diagnosis was made on average 11 days (range 2 to 29) after LSG. Six patients presented early leaks (3 weeks). Symptoms leading to leak diagnosis included abdominal pain, fever, and a biological inflammatory syndrome in the early cases (peritonitis in two cases). In the late leaks, however, symptoms included nausea, pain, and in only one case fever. In post-operative care, of the nine patients, only seven received upper GI series using diluted Gastrografin® 1 to 2 days after the procedure and all were normal. All postsleeve gastrectomy leaks were diagnosed after a CT scan with intravenous contrast, showing intraperitoneal fluid collections. Oral contrast was used in four patients with only two showing a leak on the CT scan results (Fig. 1).
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Table 1 Patient characteristics and global treatment Case no. Sex Age BMI Comorbidities
Time to leak 1st diagnosis (POD) treatment
1 2 3 4a 5 6 7a
F F F F F F M
34 33 34 65 47 25 55
38 41 43 43 37 54 52
7 22 10 6 20 4 2
DLT DLT + stent DLS DLS + stent DLS + TD + stent DLS + PCD + stent DLS + stent
8 9
F F
28 57
52 37
29 11
EID + stent + DLS DLS + stent
HBP, gonalgia, asthma SOB, gonalgia None COPD, OSAS, HBP SOB, back pain OSAS CAD, asthma, OSAS, diabetes None Back pain, HBP, OSAS
2nd Time between 1st 3rd Healing treatment and 2nd treatment treatment (PLD) Stent
– –
348 – 82 – 120 – –
TG – – – – – –
405 53 125 77 167 142 57
–
130 –
TG –
185 57
– Stent – Stent
Stent
POD post-operative day, PLD post-leak diagnosis, OSAS obstructive sleep apnea syndrome, HBP high blood pressure, COPD chronic obstructive pulmonary disease, CAD coronary artery disease, SOB shortness of breath, DLT drainage by laparotomy, PCD percutaneous drainage, DLS drainage by laparoscopy, TD thoracic drainage, EID endoscopic internal drainage, TG total gastrectomy a
Number of patients who underwent sleeve gastrectomy in our department
All patients were initially drained (average of 5 days after leak diagnosis, range 0 to 31), and only seven were initially treated using endoscopic stent (average of 14 days after leak diagnosis, range 1 to 25). Six patients benefited from external drainage (laparoscopy, laparotomy, or percutaneous) and stents. One patient had internal endoscopic drainage and stent. Two patients only benefited initially from external drainage without stent. In four cases, the leak did not heal after the first-line treatment (two cases with stent and two without), leading to a second-line treatment using endoscopic
All patients were treated by covered stents. Stent characteristics are presented in Table 3. All fistulas were visualized during the endoscopic procedure in the proximal third of the stomach, close to the gastroesophageal junction (mean distance to dental arch of 41.8 cm (range 37 to 45) when measured). One patient was diagnosed with three different synchronic fistulas (case no. 6), whereas the others had just one. All patients initially received parenteral nutrition. Among those, only six patients then received enteral nutrition through a feeding tube. Table 2 Laparoscopic sleeve gastrectomy (LSG) and leak characteristics Case no.
Sleeve caliber
Staples and sleeve reinforcement
Intraoperative blue test
Leak symptoms
CT scan results
ICU/MV
1
26 Fr
Staples and suture
Not done
Peritonitis, chest pain
Yes/no
2
Unknown
Normal
3
33 Fr
Staples and hemostatic suture back and forth Thick staples and sutures
Abdominal pain, fever, inflammatory syndrome Peritonitis
4a
36 Fr
Normal
5
36 Fr
6
36 Fr
Medium staples and stitches at staple intersections Thick staples and proximal suture Thick staples
Peritonitis, perisplenic fluid collection, pleural effusion Left subphrenic abscess with air-fluid levels Proximal staple line leak and multiple intraperitoneal fluid collections Collections with air-fluid levels
7a
36 Fr
8 9
Not done
Normal Normal
34 Fr
Medium staples and single stitches on the leak Staples + suture
Leak but normal after stitches Not done
33 Fr
Thick staples
Normal
Abdominal pain, vomiting, fever, inflammatory syndrome Abdominal pain Abdominal pain, fever, inflammatory syndrome Abdominal pain, fever Abdominal pain & vomiting Abdominal pain, fever, inflammatory syndrome
ICU intensive care unit, MV mechanical ventilation a
Number of patients who underwent Sleeve gastrectomy in our department
Left subphrenic fluid collections Left subphrenic fluid collections Subhepatic leak and pneumoperitonitis Air surrounding staple line and splenic infarction Left subphrenic fluid collections
No/no Yes/yes
Yes/yes
No/no Yes/yes No/no Yes/no Yes/no
Yes –
Number of patients who underwent Sleeve gastrectomy in our department
Removal due to poor stent tolerance
Removal due to two consecutive stent migrations c
b
a
LD leak diagnosis, GER gastroesophageal reflux, Ha. Hanarostent, Ta. Taewoong, TG total gastrectomy
– 1 9
Ta. 15 and 18 cm
8 weeks (17+39 days)
Good
–
–
No: TG
Yes –
Chest pain 8 weeks (28+32 days)
– –
Ha.
–
Good 2 weeksc (5+9 days)
132
GER 6 weeks (41d) Ha. 16
12
7*
8
25 6
Ta. 18 and 23 cm
Yes
Yes Poor
– –
4 weeks Ha.
–
120
–
Poor
Pyloric ulcer with anemia 17 weeks (28+21+28+40 days)
2 weeksa Ta. 18 cm 7 5
Ha.
Yes
Yes –
–
–
–
Good
Good
6.5 weeks Ha. 82
19
3
4b
Ha.
8 weeks (30+28 days)
–
–
No: TG
–
–
–
– –
–
–
–
–
–
Chest pain, GER, malnutrition
Good Ha. 21 2
6 weeksa Ha. 348 1
4.5 weeks
Stent tolerance Total stent treatment duration Stent type Delay LD, 2nd stent (days) Stent type
Stent tolerance Delay LD, 1st stent (days)
Total stent treatment duration
2nd stent treatment 1st stent treatment Case no.
stent (average of 170 days after leak diagnosis, range 82 to 348). Premature stent removal took place in three cases (33.3 %). Patients had poor stent tolerance in six cases (mainly chest pain and gastroesophageal reflux), leading to total stent removal in two cases: in case no. 5, a successful second-line stent treatment was possible, whereas in case no. 1, the stent treatment was a failure. In one case (no. 8), the stent (Taewoong®, 18 cm) migrated after 5 days and was replaced by a longer stent (Taewoong® 23 cm) which migrated again 9 days later, leading to total stent removal. Both stents migrated distally uncovering the fistula (located in the proximal third of the stomach) and thus becoming ineffective. The mean total stent treatment duration was 6.4 weeks (range 2 to 17). In three cases, the stent was removed without replacement and without fistula healing (one due to migration and two due to poor tolerance). In four other cases, a new stent had to be placed after the stent removal due to fistula persistence, in order to prolong the stent treatment. The mean stent duration in these patients before the first replacement was 25 days (range 17 to 30). The treatment by covered stents was successful except in two cases (case nos. 1 and 8) with a success rate of 78 %. In those two cases, stent failure led to a final treatment by total gastrectomy with uneventful follow-up. Correct healing of the leak was confirmed in all cases by endoscopy showing healing of the fistula visually and the absence of contrast leak after opacification. There were no post-operative deaths, even in the long-term follow-up. The patients had a mean follow-up time of 10.7 months (range 1 to 25) after stent removal without relapse. The mean healing period was 141 days (range 53 to 405). For the five patients with early stent treatment (≤3 weeks after leak diagnosis), the mean healing period was 99 days (range 53 to 185) versus 224 days (range 125 to 405) for the four others.
Table 3 Stent characteristics
Fig. 1 Left subphrenic fluid collections with drainage. Esophageal Hanarostent® covering the fistula and duodenal feeding tube
Yes
OBES SURG (2013) 23:687–692 Stent success
690
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Discussion From our experience, the best way to reduce post-LSG gastric leak healing time seems to be early covered selfexpandable stent treatment using Hanarostent® (within the first 3 weeks) for 6 weeks, associated with an immediate laparoscopic or percutaneous drainage of collections and enteral nutrition. The stent treatment was successful in 78 % of cases. When patients received this standardized treatment in our institution (case nos. 2, 4, and 7), the average healing time was only 62 days. This study confirms facts about the LSG procedure and gastric leak diagnosis known in the literature. Gastric leak gravity was confirmed with 66 % of our patients needing intensive care, and half of those, mechanical ventilation. No particular characteristic (of patients or LSG procedure), especially staple line reinforcement, analyzed in this study could be associated with fistula gravity and treatment difficulty [30, 31]. Early and late gastric leaks had approximately the same healing time (144 versus 135 days). Postoperative upper GI series did not exclude a gastric leak: in this study, they found 0 % of the leaks and only 28 % in other studies [13, 24]. The CT scan was the best noninvasive method to confirm the diagnosis, assess the gravity, and facilitate therapeutic decision. During the endoscopy, leaks were all found in the proximal third of the stomach [16, 25]. Use of coated self-expandable stents has already been proven to efficiently treat gastric leaks [27, 32–34]. One of the advantages of stent treatment is the possibility of immediate oral nutrition and early patient discharge, which limits hospital-induced complications, facilitates patient recovery, and reduces costs [23, 32]. These patients’ partial and temporary malnutrition is however not comparable in its gravity to cancer patients. Stents must be used when there is certain gravity to the leak on CT scan. One patient (not included in this study) with only air bubbles, fat infiltration, and without fluid collections was successfully treated in 20 days without stent (sole medical treatment for 2 weeks). Stent treatment was successful in 78 % of cases in this study compared to 88 % in the literature (range 50 to 100 %) [17, 19, 20, 22, 26–29]. This study seems to show that covered self-expandable stents reduce healing time if used early (12,000 cases. Surg Obes Relat Dis. 2012;8:8–19. 4. Agence Technique de l'Information sur l'Hospitalisation, 2012. Available from www.atih.sante.fr 5. Prasad P, Tantia O, Patle N, et al. An analysis of 1–3-year followup results of laparoscopic sleeve gastrectomy: an Indian perspective. Obes Surg. 2012;22:507–14. 6. Fuks D, Verhaeghe P, Brehant O, et al. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009;145:106–13. 7. Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg. 2010;252:319–24. 8. Abbatini F, Capoccia D, Casella G, et al. Type 2 diabetes in obese patients with body mass index of 30-35 kg/m2: sleeve gastrectomy versus medical treatment. Surg Obes Relat Dis. 2012;8:20–4. 9. Wong SK, Kong AP, So WY, et al. Use of laparoscopic sleeve gastrectomy and adjustable gastric banding for suboptimally controlled diabetes in Hong Kong. Diabetes Obes Metab. 2011;14:372–4. 10. Lee WJ, Hur KY, Lakadawala M, et al. Gastrointestinal metabolic surgery for the treatment of diabetic patients: a multi-institutional international study. J Gastrointest Surg. 2012;16:45–52. 11. Bohdjalian A, Langer FB, Shakeri-Leidenmuhler S, et al. Sleeve gastrectomy as sole and definitive bariatric procedure: 5-year results for weight loss and ghrelin. Obes Surg. 2010;20:535–40. 12. Weiner RA, Weiner S, Pomhoff I, et al. Laparoscopic sleeve gastrectomy—influence of sleeve size and resected gastric volume. Obes Surg. 2007;17:1297–305. 13. Burgos AM, Braghetto I, Csendes A, et al. Gastric leak after laparoscopic-sleeve gastrectomy for obesity. Obes Surg. 2009;19:1672–7. 14. Hamoui N, Anthone GJ, Kaufman HS, et al. Sleeve gastrectomy in the high-risk patient. Obes Surg. 2006;16:1445–9.
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