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

May 7, 2018 updated by: Antti Siiki, Tampere University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital, Dept. of Gastroenterology and Alimentary Tract Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post-cholecystecomy bile leak
Endoscopic insertion of biodegradable biliary stent
Device: Endoscopic insertion of biodegradable biliary stent
Endoscopic insertion of biodegradable biliary stent
Other Names:
  • Braided, self-expanding polydioxanone stent, Ella, Czech Rep
Experimental: Benign biliary stricture
Endoscopic insertion of biodegradable biliary stent
Device: Endoscopic insertion of biodegradable biliary stent
Endoscopic insertion of biodegradable biliary stent
Other Names:
  • Braided, self-expanding polydioxanone stent, Ella, Czech Rep

What is the study measuring?

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
Time Frame: The follow-up of 12 months after stent implantation
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
Time Frame: 30 days from stent implantation, late adverse events up to 12 months
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
Time Frame: intraoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Study Director: Johanna Laukkarinen, Md, PhD, Dept. of Gastroenterology and Alimentary Tract Surgery
  • Study Director: Juhani Sand, Md, PhD, Dept. of Gastroenterology and Alimentary Tract Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biodegradable Biliary stent

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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