Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Biliary Stent

Study Overview
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Brief Summary
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Patients with either post-cholecystectomy bile leak or benign biliary stricture are recruited for endoscopic insertion of a biodegradable biliary stent. A follow-up of 12 months with repeated serum samples and magnetic resonance imaging is scheduled. The primary end points are feasibility of endoscopic insertion with the novel implantation device and stricture or leak resolution as well as clinical treatment success.

Detailed Description
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Benign biliary strictures (BBS) and post-cholecystectomy bile leaks have traditionally been treated endoscopically with plastic stents. In BBS, promising results of covered self-expanding metal stent use have been recently published. However, in both BBS and post-cholecystectomy bile leak the need of stent therapy is temporary and endoscopic stent exchange or removal is unavoidable. These two groups of patients may be the ones that would most obviously benefit from biodegradable (BD) biliary stents. Studies of BD stents on animal models have shown excellent long term patency and safety both in biliary and pancreatic duct as well better outcome compared to plastic stents after post-cholecystectomy bile leak in an animal study. Until recently, non-operative insertion of BD polydioxanone stent in human biliary tract has been possible only via percutaneous route. With the novel implantation device, the BD stents (braided, self-expanding polydioxanone stent, 8 x 40-60mm, Ella, Czech republic) may be used endoscopically during endoscopic retrograde cholangio-pancreatography (ERCP). The hypothesis is that larger diameter and radial expansion strength provide at least similar treatment success as the current method of endoscopic insertion of plastic or covered self-expanding metal stents in bile leak and BBS, respectively. However, later stent exchange or removal is not necessary with BD stents.

Official Title
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Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Polydioxanone Biliary Stent

Conditions
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Biliary Tract Diseases

Intervention / Treatment
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* Device: Endoscopic insertion of biodegradable biliary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed-consent patients with diagnosed or suspected post-cholecystectomy biliary leak or benign biliary stricture. Exclusion Criteria: Patients with contra-indications for magnetic resonance imaging (MRI) or surgically altered gastro-duodenal anatomy (e.g. roux-y-loop) are excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-cholecystecomy bile leak<br>Endoscopic insertion of biodegradable biliary stent | Device: Endoscopic insertion of biodegradable biliary stent<br>* Endoscopic insertion of biodegradable biliary stent<br>* Other names: Braided, self-expanding polydioxanone stent, Ella, Czech Rep;|
| Experimental: Benign biliary stricture<br>Endoscopic insertion of biodegradable biliary stent | Device: Endoscopic insertion of biodegradable biliary stent<br>* Endoscopic insertion of biodegradable biliary stent<br>* Other names: Braided, self-expanding polydioxanone stent, Ella, Czech Rep;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical treatment success of stricture or leakage, treatment failure rate measured by change in treatment protocol or unplanned interventions, radiologic stricture diameter in MRI, radiologic stent degradation in MRI | Stent patency, unplanned admissions and interventions, signs of cholangitis during treatment assessed by repeated liver function tests, magnetic resonance imaging and interview. Change in stent diameter and gradual radiologic dissappearance due to degradation assessed by repeated MRI and liver function tests, stricture resolution assessed by repeated MRI and radiologic measurement of stricture width as well as liver function tests, leakage resolution assessed by disappearance of biliary fluid collection in MRI and liver function tests | The follow-up of 12 months after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERCP complications, late adverse events during stent therapy | endoscopic retrograde cholangio-pancreatography (ERCP) and stent implantation related complications graded mild-moderate-severe according to Cotton et al 1991, unplanned admissions and incidence of late adverse events such as acute cholangitis until up to 12 months of follow-up assessed by repeated MRI, phone interview, blood samples and review of patient records at each follow-up contact. | 30 days from stent implantation, late adverse events up to 12 months | 
| Technical success of stent insertion | To assess the usefulness and safety of a novel endoscopic implantation device measured by success rate of stent implantation and evaluation possible intra-procedural technical challenges during ERCP | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biodegradable stents, ERCP