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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353286
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Antti Siiki, Tampere University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Biliary Tract Diseases Device: Endoscopic insertion of biodegradable biliary stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Polydioxanone Biliary Stent
Study Start Date : May 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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 Name: 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 Name: Braided, self-expanding polydioxanone stent, Ella, Czech Rep




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353286


Locations
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Finland
Tampere University Hospital, Dept. of Gastroenterology and Alimentary Tract Surgery
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antti Siiki, MD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02353286    
Other Study ID Numbers: Biodegradable Biliary stent
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Antti Siiki, Tampere University Hospital:
Biodegradable stents, ERCP
Additional relevant MeSH terms:
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Biliary Tract Diseases
Digestive System Diseases