Gastric leak after laparoscopic sleeve gastrectomy: management with endoscopic double pigtail drainage. A systematic review

Accepted Manuscript Gastric Leak After Laparoscopic Sleeve Gastrectomy: Management with Endoscopic Double Pigtail Drainage. A Systematic Review Antonio Giuliani, MD, PhD, Lucia Romano, MD, Michele Marchese, MD, PhD, Stefano Necozione, MD, Giovanni Cianca, MD, Mario Schietroma, MD, Francesco Carlei, MD. PII:

S1550-7289(19)30087-5

DOI:

https://doi.org/10.1016/j.soard.2019.03.019

Reference:

SOARD 3689

To appear in:

Surgery for Obesity and Related Diseases

Received Date: 10 February 2019 Revised Date:

26 February 2019

Accepted Date: 13 March 2019

Please cite this article as: Giuliani A, Romano L, Marchese M, Necozione S, Cianca G, Schietroma M, Carlei F, Gastric Leak After Laparoscopic Sleeve Gastrectomy: Management with Endoscopic Double Pigtail Drainage. A Systematic Review, Surgery for Obesity and Related Diseases (2019), doi: https:// doi.org/10.1016/j.soard.2019.03.019. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT GASTRIC LEAK AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY: MANAGEMENT WITH ENDOSCOPIC DOUBLE PIGTAIL DRAINAGE. A SYSTEMATIC REVIEW

Running head: Pigtail drainage in gastric leak

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Antonio GIULIANI1, MD, PhD, Lucia ROMANO1*, MD, Michele MARCHESE2, MD, PhD, Stefano NECOZIONE3, MD, Giovanni CIANCA1, MD, Mario SCHIETROMA1, MD, Francesco CARLEI1, MD. 1

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Department of General Surgery, San Salvatore Hospital. Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy 2 Surgical Endoscopy Unit, San Salvatore Hospital, L'Aquila, Italy 3 Epidemiology Unit, Department of Life, Health and Environmental Sciences, University of L’Aquila, L'Aquila, Italy

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*Corresponding author

Acknowledgments

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Correspondence to: Lucia Romano University of L’Aquila Dipartimento di Scienze Cliniche Applicate e Biotecnologiche 67100 Coppito (AQ) ITALY Tel: +39.0862368550 Fax: +39.0862368550 e-mail: [email protected]

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All authors disclose the absence of any financial and personal relationships with other people or organizations that could inappropriately influence (bias) their work.

Conflict of Interest

The authors declare that they have no conflict of interest.

Funding Information No funding.

ACCEPTED MANUSCRIPT Abstract: Gastric leak remains the main complication after sleeve gastrectomy, but there are no

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standardized guidelines for its treatment. Good results have been reported using endoscopic double-

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pigtail stent. In order to estimate its effectiveness, we carried out this systematic review. Eleven

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eligible articles were identified by searching PubMed, Embase and Cochrane library. Three-

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hundred-eighty-fivepatients met inclusion criteria. The pooled proportion of successful leak

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closures by using double pigtail drainage was 83.41% The proportion of successful leak closures by

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using double pigtail drainage by experienced operators as first line treatment was 84.71% Our

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review suggested that double-pigtail stent could be a valid approach to manage the post-bariatric

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gastric leak, with low rate of complications and a good tolerance by patients. More high-quality

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studies with large samples sizes should be undertaken to better evaluate and compare the variety of

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techniques available.

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Keywords: sleeve; leak; fistula; pigtail; internal drainage; systematic review

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INTRODUCTION

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Laparoscopic Sleeve Gastrectomy (LSG) is one of the main surgical options for the treatment of

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obesity and its comorbidities. Gastric leak remains the first complication after this kind of surgery,

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and it often occurs in the upper part of the staple line (1, 2, 3, 4). According to a recent meta-analysis

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(5)

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available, there are no standardized guidelines for the treatment of gastric leak. Focusing on

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endoscopic management, historically treatment of leak involved closing devices (endoclips, over-

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the-scope clips and biological glue) or devices like covered Self-Expandable Metallic Stents

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(SEMS). More recently, good results have been reported using a Double-Pigtail Stent (DPS) for

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internal drainage of the gastric leak, allowing a shorter hospital stay and facilitating perioperative

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management. For these reasons, a DPS is now becoming the standard of treatment for gastric leak in

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many centres. The principle is to endoscopically guide the drainage through the staple line orifice,

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, this adverse event has an incidence of 2.2 per cent. Because of the variety of techniques

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ACCEPTED MANUSCRIPT to favour the internal drainage of the abscess cavity and the obstruction of the leak’s orifice, and to

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induce mechanical re-epithelialization along its pathway. To date, many studies have investigated

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the safety and efficacy of DPS, but their results remain inconsistent and only a limited number of

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them report a significant sample size. In order to estimate the effectiveness of DPS and to help

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surgeons and endoscopists make a better decision in the management of the staple line leak, we

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carried out this systematic review on all the eligible papers.

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The aim of our work is to carry out a comprehensive literature review on the efficacy of the DPS endoscopically positioned to treat leak post-sleeve gastric resection.

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MATERIALS AND METHODS

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A protocol was drafted before the initial search was started. The present review was conducted and

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reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses

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(PRISMA) statement issued in 2009 (6).

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In August 2018, we conducted a systematic search in the electronic literature of PubMed,

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Embase and Cochrane library for all relevant reports, using the search terms “sleeve”, “leak or

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leakage or fistula” and “pigtail or internal drainage”. The following combinations were used:

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“Sleeve AND Leak”, “Sleeve AND Fistula”, “Gastric leak AND Pigtail”, “Gastric leak AND

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Internal Drainage”. In addition, published studies of which the authors were aware were added to

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the list of publication, also if they did not appear in the search results. The search was limited to

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English language papers. A PRISMA flow chart of the search strategy is shown in Figure 1.

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We included studies that investigated gastric leak following sleeve gastrectomy and that had

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as primary or secondary endpoints to evaluate the efficacy of a treatment strategy based on trans-

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fistulary internal drainage with double-pigtail plastic stents, endoscopically positioned. Full journal

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publications were required. Brief abstracts were excluded. Case reports, letters to editor, brief

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communications were not included. We also excluded studies in which a limited and defined

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population was elected, i.e. patients >65 years old (Figure 1). 2

ACCEPTED MANUSCRIPT Abstracts and full-text articles complying with the inclusion criteria were screened, and the

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following information was entered into a structured Excel data table: study characteristics (i.e. the

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first author's last name, year of publication, country of participating institution, type of study,

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endpoints, sample size), patients characteristics (i.e. age, sex), treatment proposed, time between

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surgery and treatment, results (i.e. results considered, results obtained, duration of follow-up),

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complications. An assessment form from the Cochrane Handbook was used to assess the quality of

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selection, performance, detection, attrition, and reporting biases of each eligible study as low,

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unclear and high risk of bias (2011).

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Among all the patients, we considered those who met the following inclusion criteria: a)

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underwent laparoscopic sleeve gastric resection, b) with confirmed gastric leak and c)

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endoscopically treated with double-pigtail stent (as first line or second line treatment). We excluded

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patients treated with pigtail in association with another solution (i.e. SEMS) and patients in whom

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pigtail has been placed under radiological guidance and not endoscopically. The patients who met

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these criteria were 385. Their characteristics are summarized in Table 1.

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In all the studies, leak was defined as contrast extravasation through staple line detected

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during oral contrast CT scan. The diagnosis had to be confirmed by upper gastrointestinal

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endoscopy. The clinical presentation, time to onset and site of the gastric leak along the staple line

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were defined according to the modified UK Surgical Infection Study Group definitions (7, 8).

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RESULTS

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A total of 60 publications were identified for potential inclusion. After removal of 27 duplicated,

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exclusion of an article not in English, and exclusion of another 10 based on title and/or abstract, full

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text of 22 eligible publications were screened. Of these, 11 were excluded for different reasons.

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The PRISMA(6) flow diagram is presented in Figure 1. Finally, a total of 11 eligible articles were

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included in our systematic review.

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The characteristics of the 11 selected studies are summarized in Table 2

(9-19)

. In all cases

data were collected in prospectively maintained database and were retrospectively analysed. These

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studies were published between 2012 and 2018, involving 681 participants. The sample size of the

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studies ranged from 19 to 112. Ten studies were carried out in Europe (nine in France and one in

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Belgium), and one study was done in Australia.

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All the studies considered are non-randomized, retrospective study, so we can not talk about

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selection bias. Because of the nature of the clinical surgery trials, it was impossible to perform exact

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blinding except for the statistician. We can assess a low risk of attrition bias, because there are not

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missing outcome data. We can also judge as low the risk of reporting bias, as far as the study

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protocol is available and all the pre-specified (primary and secondary) outcomes of the studies that

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are of interest in the review have been reported.

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All the studies considered clinical success as absence of residual fluid collection on CT scan,

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absence of free contrast medium extravasation in the peritoneal cavity neither around the stomach

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nor through fistula orifice and discharge of the patient on a normal diet, without fistula recurrence

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after 6-month follow-up. Pseudodiverticula communicating with gastric tube with assured internal

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emptying was considered acceptable. Some studies (11, 13) also considered technical success, defined

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as the successful insertion of at least two pigtails (either stent or catheter) across the leak. In

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contrast, “treatment failure”

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treatment or the death of the patient. Patients who were lost to follow-up were considered as failures

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for statistical analysis. In some cases (9, 12, 13, 14, 15, 16) there is duplication of studies. In

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particular, there is overlap between studies 9 and 16, 12 and 13, 14 and 15, because these couples of

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studies assess the same population of patients, but at different times and with different numbers.

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Therefore, for the purposes of statistical analysis, we taken into account the value of these overlaps.

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was defined as the need for surgery despite endoscopic

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(15, 16, 19)

Two studies

(14, 19)

gave only a qualitative analysis of the results: Cosse et al.

(14)

, in their

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study about cost-effectiveness of stent type in endoscopic treatment of gastric leak, found that the

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efficacy of the DPS strategy was observed during the first 2 months of management, and they 4

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affirm that DPS should be considered as the standard for treatment of gastric leak after LSG.

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Christophorou et al

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interesting to evaluate the efficacy of this technique compared with others. Because these two

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studies did not specify the exact number of cases considered positive, they had to be excluded from

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the overall assessment, for the metanalytic evaluation with related confidence intervals.

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For the specific statistical analysis, the total number of patients considered was 211.

affirms that endoscopic drainage seems to be effective and that it would be

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(19)

The metanalytic evaluation of results found that the global proportion of successful leak (9, 11, 16)

closures by using DPS was 83.41 %. Three studies

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internal drainage was used as first line treatment and those in which it was used as a rescue therapy,

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i.e. after failure of other treatments. Considering again the overlap between studies 9 and 16,

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patients treated with pigtail drainage as first line strategy were 170. The proportion of successful

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leak closures by using DPS as first line treatment was 84.71%. Patients treated with pigtail drainage

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as rescue therapy were 41. The proportion of successful leak closures by using DPS as rescue

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therapy was 78.05%. Four studies

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distinguished between cases in which

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(11, 12, 13, 16)

reported time between bariatric surgery and drainage: Bouchard et

al. reported a time interval of 47 days, distinguishing if drainage was primary treatment (14 days) or

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second line treatment after a failure of previous one (96 days). The time interval described by

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Donatelli, Ferretti et al.

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their second work

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endoscopic drainage was <30 days in 74% of patients. Christophorou et al. (19) affirmed that the first

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endoscopy was performed in a median of 6 days following initial diagnosis of the leak, and the

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median time to leak occurrence was 10 days following LSG. It seemed that the preferred pigtail

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diameter was 7 Fr, while the length was mainly determined by characteristics of the fistula tract

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11, 12, 13, 17, 18)

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(12)

was 25.6 days in their first paper, while they talked about 60.5 days in

(13)

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. In the study of Lorenzo et al. the time between bariatric surgery and

(9,

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Concerning the patients management, two authors

(11, 18)

described the use of parenteral

nutrition in the first days (for one week or more, or in any case until it was performed a CT scan, 5

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whose date was decided on the basis of the clinical trend). In four studies enteral nutrition was

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preferred,

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clinical judgment.

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Five studies

mainly trans nasojejunal tube or feeding jejunostomy, and maintained until

(9, 10, 13, , 18, 19)

reported mean time of healing. Global calculated mean time of

healing in all these studies was 118.1 days (range 57,5 – 227).

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(12, 13, 14, 17)

Most studies mentioned common post-endoscopic complications, as bleeding, drainage

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migration, perforation, gastrobronchial fistula, persistentgastric leak, splenic hematoma, stricture,

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bleeding ulcer, peritonitis, wall incarceration. Total number of complications was 28 cases out 204

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patients (13.73 %), reported in 6 studies

(9, 10, 11, 13, 15, 18)

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. Gonzalez, Lorenzo et al.

(9)

reported that

more overall complications were observed when DPS was used as second-line treatment (47% of

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complications vs 4.7% when DPS was used as first line treatment). The details of complications are

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reported in Table 3.

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DISCUSSION

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LSG remains one of the main surgical options for the treatment of obesity. Gastric leak is the most

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feared and life-threatening complication after this kind of surgery. Many strategies have been

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proposed for its management, but nowadays well-established guidelines are missing. Interventional

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endoscopic techniques are becoming more frequently used, such as placement of covered gastric

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stents or endoscopic clips, application of biological glue, endoscopic drainage (nasocavitary drains

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or double-pigtail catheters), and placement of fistula plugs. Among these, the use of DPS is

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spreading as treatment in many centres, facilitating perioperative management of gastric leak. In

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fact, from the analysis of the literature, this approach seems to be efficacious, well tolerated, and

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with shorter healing time than other frequently used endoscopic procedures.

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Under general anesthesia and oral endotracheal intubation, upper GI endoscopy is performed

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using standard gastroscopes. The procedure starts with endoscopic contrast study in order to better

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characterize the fistula tract and the communicating abdominal collection. Under fluoroscopic 6

ACCEPTED MANUSCRIPT guidance, a guidewire is advanced into the communicating collection. Using the guidewires in

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place, trans-fistulary drainage is achieved by placing double-pigtail plastic stents. Procedure can be

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repeated if leak orifice is large enough to accommodate two stents. DPS works by promoting the

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drainage of the abscess into the gastric cavity, preventing the contact of the purulent liquid with the

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leak’s orifice and thus favouring its closure and re-epithelialization.

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From our systematic review, it results that the pooled proportion of successful leak closures (14)

by using DPS is 83.41%. Using of DPS seems also to reduce costs

by making management

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easier, shortening hospital stay and allowing patients to achieve early re-alimentation. It is

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important to underline that DPS works with a very low complication rate. It is in fact reported in out

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review a global complication rate of 13.73%. The main one seems to be drainage migration, with

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the risk of splenic parenchymal abscess or haemorrhage. This eventuality is reported in the

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literature (20, 21, 22) and requires early endoscopic removal of the stent.

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An important limitation to the use of DPS is however represented by the expertise of the

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practitioners. Not all centres have in fact an endoscopic department qualified to apply these devices,

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and the competency of the operators is obviously essential for the success of the treatment. This

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limit could be considered as a bias, since the choice to use or not the drainage could be guided by

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the preference of endoscopists towards methods that they are more accustomed to.

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We decided to conduct a literature systematic review that identified whether DPS has

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advantages as a treatment for post bariatric gastric leak. We hope it could be helpful to clinicians to

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correctly deal with the management of leak after Sleeve gastrectomy. It included 11 studies. The

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results showed that DPS had high rate of successful leak closures (83.41% in total and 84.71% as

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first line treatment). To our best knowledge, there's no previous review evaluating the effects of this

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endoscopic management. There are some limitations in this review that must be addressed. The first

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one is that the sample size was relatively small. Second, because of the nature of clinical surgery

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trials, the blinding could not be exactly performed, so it affected the methodological quality of the

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included trials.

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CONCLUSION

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In conclusion, our paper suggested that DPS could be a valid approach to manage the post- sleeve

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gastrectomy leak, with low rate of complications and a good tolerance by patients. More high-

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quality studies with large samples sizes should be undertaken to better evaluate and compare the

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variety of techniques available. Trials with comparative assessments with other techniques should

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also be encouraged.

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This article does not contain any studies with human participants or animals performed by any of

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the authors.

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Conflict of Interests – The authors certify that there is no conflict of interest with any financial

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organization regarding the material discussed in the manuscript.

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Acknowledgments: We are grateful to the Anonymous Reviewers for the contribution provided to

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the improvement of the article.

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REFERENCES: 1) Buchwald H, Ikramuddin S, Dorman RB, et al. Management of the metabolic/ bariatric surgery patient. Am J Med 2011;124:1099-105.

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2) Rosenthal RJ, Diaz AA, et al. International Sleeve Gastrectomy Expert Panel Consensus

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Statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat

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Dis 2012;8:8-19.

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3) Moszkowicz D, Arienzo R, Khettab I et al. Sleeve gastrectomy severe complications: is it always a reasonable surgical option? Obes Surg 2013; 23: 676 – 686.

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4) Giuliani A, Romano L, Papale E, et al. Complications post-laparoscopic sleeve gastric

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resection: review of surgical technique. Minerva Chir. 2019 Feb 13. doi: 10.23736/S0026-

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4733.19.07883-0.

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5) Parikh M, Issa R, McCrillis A, et al. Surgical strategies that may decrease leak after

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laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann

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Surg 2013; 257: 231–237.

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6) D. Moher, A. Liberati, J. Tetzlaff, et al., Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, PLoS Med. 2009;6(7):e1000097 7) Csendes A, Burdiles P, Burgos AM, et al. Conservative management of anastomotic leaks

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after 557 open gastric bypasses. Obes Surg 2005; 15: 1252–1256. 8) Bruce J, Krukowski ZH, Al-Khairy G, et al. Systematic review of the definition and

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measurement of anastomotic leak after gastrointestinal surgery. Br J Surg 2001; 88: 1157–

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9) Gonzalez JM, Lorenzo D, Guilbaud T et al. Internal endoscopic drainage as first line or

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second line treatment in case of postsleeve gastrectomy leaks. Endosc Int Open. 2018

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Jun;6(6):E745-E750.

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10) Rebibo L, Bartoli E, Dhahri A, et al. Persistent gastric fistula after sleeve gastrectomy: an

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analysis of the time between discovery and reoperation.

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Jan;12(1):84-93.

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Surg Obes Relat Dis. 2016

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11) Bouchard S, Eisendrath P, Toussaint E, et al. Trans-fistulary endoscopic drainage for post-

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bariatric abdominal collections communicating with the upper gastrointestinal tract.

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Endoscopy. 2016 Sep;48(9):809-16. 12) Donatelli G, Ferretti S, Vergeau BM, et al. Endoscopic Internal Drainage with Enteral

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Nutrition (EDEN) for treatment of leaks following sleeve gastrectomy. Obes Surg. 2014

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Aug;24(8):1400-7.

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13) Donatelli G, Dumont JL, Cereatti F, et al. Treatment of Leaks Following Sleeve Gastrectomy by Endoscopic Internal Drainage (EID). Obes Surg. 2015 Jul;25(7):1293-301.

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14) Cosse C, Rebibo L, Brazier F, et al. Cost-effectiveness analysis of stent type in endoscopic

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treatment of gastric leak after laparoscopic sleeve gastrectomy. Br J Surg. 2018

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Apr;105(5):570-577.

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15) Pequignot A, Fuks D, Verhaeghe P, et al. Is there a place for pigtail drains in the

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management of gastric leaks after laparoscopic sleeve gastrectomy? Obes Surg. 2012

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May;22(5):712-20.

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16) Lorenzo D, Guilbaud T, Gonzalez JM, et al. Endoscopic treatment of fistulas after sleeve

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gastrectomy: a comparison of internal drainage versus closure. Gastrointest Endosc. 2018

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Feb;87(2):429-437.

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17) Talbot M, Yee G, Saxena P. Endoscopic modalities for upper gastrointestinal leaks, fistulae and perforations. ANZ J Surg. 2017 Mar;87(3):171-176.

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18) Nedelcu M, Manos T, Cotirlet A, et al. Outcome of leaks after sleeve gastrectomy based on

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a new algorithm adressing leak size and gastric stenosis. Obes Surg. 2015 Mar;25(3):559-

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63.

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19) Christophorou D, Valats JC, Funakoshi N, et al. Endoscopic treatment of fistula after sleeve

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gastrectomy: results of a multicenter retrospective study. Endoscopy. 2015 Nov;47(11):988-

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96.

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20) Donatelli G, Airinei G, Poupardin E, et al. Double-pigtail stent migration invading the

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spleen: rare potentially fatal complication of endoscopic internal drainage for sleeve

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gastrectomy leak. Endoscopy 2016; 48 Suppl 1 UCTN: E74-5. 21) Genser L, Pattou F, Caiazzo R. Splenic abscess with portal venous gas caused by

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intrasplenic migration of an endoscopic double pigtail drain as a treatment of post–sleeve

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gastrectomy fistula. Surg Obes Relat Dis 2016; 12(1):e1-3.

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22) Marchese M, Romano L, Giuliani A, et al. A case of intrasplenic displacement of an

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endoscopic double-pigtail stent as a treatment for laparoscopic sleeve gastrectomy leak. Int J

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Surg Case Rep. 2018; 53:367-369.

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ABBREVIATIONS:

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LSG: Laparoscopic Sleeve Gastrectomy

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SEMS: Self-Expandable Metallic Stents

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DPS: Double-Pigtail Stent

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ACCEPTED MANUSCRIPT Table 1 - Characteristics of the patients

SURGERY

MEAN AGE

SEX

Gonzales, Lorenzo [9]

LSG

Group 1: 43+-11 Group 2: 43+-14

Group 1: 16F, 6M Group 2: 16F, 6M

Rebibo, Bartoli [10]

LSG

39,7

Bouchard, Eisendrath [11]

LSG

42

Donatelli, Ferretti [12]

LSG

41

Donatelli, Dumont [13]

LSG

43

Cosse, Rebibo [14]

LSG

38

Pequignot, Fuks [15]

LSG

Lorenzo, Guilbaud [16]

LSG

Talbot, Yee [17]

LSG

Nedelcu, Manos [18]

LSG

Christophorou, Valats [19]

LSG

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57 F, 10 M

(n=89) 73 F, 16 M

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LSG: Laparoscopic Sleeve Gastrectomy F: females M: males

78 F (90.7%)

41

21 F, 4 M

42

78F, 22 M

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Group A: 32.4 Group B: 34 39,7

Group A: 6F, 3M B: 7 F, 3M 92 F, 18 M

Group

ACCEPTED MANUSCRIPT Table 2: Characteristics of the selected studies

COUNTRY

NUMBER OF PATIENTS

Gonzales, Lorenzo [9]

2018

France

44

Rebibo, Bartoli [10]

2016

France

86

47

Bouchard, Eisendrath [11]

2016

Belgium

Donatelli, Ferretti [12]

2014

France

Donatelli, Dumont [13]

2015

France

Cosse, Rebibo [14]

2018

France

Pequignot, Fuks [15]

2012

France

Lorenzo, Guilbaud [16]

2017

France

Talbot, Yee [17]

2015

Australia

Nedelcu, Manos [18]

2015

France

Christophorou, Valats [19]

2014

France

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DPS: Double-Pigtail Stent

33

33

21

21

67

67

112

89

25

7

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AUTHOR

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YEAR

NUMBER OF PATIENTS TREATED WITH DPS 44

100

44

64

7

19

6

110

20

ACCEPTED MANUSCRIPT Table 3 - Details of complications

NUMBER OF PATIENTS TREATED WITH DPS 44

COMPLICATIONS

Rebibo, Bartoli [10]

47

4

Bouchard, Eisendrath [11]

33

4

Donatelli, Dumont [13]

67

6

Pequignot, Fuks [15]

7

2

Nedelcu, Manos [18]

6

1

204

28

Gonzales, Lorenzo [9]

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Total

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DPS: Double-Pigtail Stent

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ACCEPTED MANUSCRIPT HIGHLIGHTS Gastric leak remains the main complication after sleeve gastrectomy, but there are no standardized guidelines for its treatment. To date, many studies have investigated the safety and efficacy of DPS, but their results remain inconsistent and only a limited number of them report a significant sample size.

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To our best knowledge, there's no previous review evaluating the effects of this endoscopic management.

The aim of our work is to carry out a comprehensive literature review on the efficacy of the DPS endoscopically positioned to treat leak post-sleeve gastric resection.

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The results showed that DPS had high rate of successful leak closures (84.42% in total and 85.92% as first line treatment).