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

NCT02353286 | Completed DMC

• 1 other identifier: Biodegradable Biliary stent
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Diseases

Keywords

Biodegradable stents, ERCP

Outcome Measures

Primary Outcomes (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

  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 Outcomes (2)

• ERCP complications, late adverse events during stent therapy

  30 days from stent implantation, late adverse events up to 12 months

• Technical success of stent insertion

  intraoperative

Study Arms (2)

Post-cholecystecomy bile leak

EXPERIMENTAL

Endoscopic insertion of biodegradable biliary stent

Device: Endoscopic insertion of biodegradable biliary stent

Benign biliary stricture

EXPERIMENTAL

Endoscopic insertion of biodegradable biliary stent

Device: Endoscopic insertion of biodegradable biliary stent

Interventions

Endoscopic insertion of biodegradable biliary stent DEVICE

Endoscopic insertion of biodegradable biliary stent

Also known as: Braided, self-expanding polydioxanone stent, Ella, Czech Rep

Benign biliary stricture; Post-cholecystecomy bile leak

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed-consent patients with diagnosed or suspected post-cholecystectomy biliary leak or benign biliary stricture.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

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

Tampere, 33521, Finland

Location

Related Publications (6)

• Mauri G, Michelozzi C, Melchiorre F, Poretti D, Tramarin M, Pedicini V, Solbiati L, Cornalba G, Sconfienza LM. Biodegradable biliary stent implantation in the treatment of benign bilioplastic-refractory biliary strictures: preliminary experience. Eur Radiol. 2013 Dec;23(12):3304-10. doi: 10.1007/s00330-013-2947-2. Epub 2013 Jul 11.

  PMID: 23842947 BACKGROUND

• Laukkarinen J, Nordback I, Mikkonen J, Karkkainen P, Sand J. A novel biodegradable biliary stent in the endoscopic treatment of cystic-duct leakage after cholecystectomy. Gastrointest Endosc. 2007 Jun;65(7):1063-8. doi: 10.1016/j.gie.2006.11.059.

  PMID: 17531643 BACKGROUND

• Grolich T, Crha M, Novotny L, Kala Z, Hep A, Necas A, Hlavsa J, Mitas L, Misik J. Self-expandable biodegradable biliary stents in porcine model. J Surg Res. 2015 Feb;193(2):606-12. doi: 10.1016/j.jss.2014.08.006. Epub 2014 Aug 9.

  PMID: 25201575 BACKGROUND

• Lorenzo-Zuniga V, Moreno-de-Vega V, Marin I, Boix J. Biodegradable stents in gastrointestinal endoscopy. World J Gastroenterol. 2014 Mar 7;20(9):2212-7. doi: 10.3748/wjg.v20.i9.2212.

  PMID: 24605020 BACKGROUND

• Siiki A, Rinta-Kiikka I, Sand J, Laukkarinen J. A pilot study of endoscopically inserted biodegradable biliary stents in the treatment of benign biliary strictures and cystic duct leaks. Gastrointest Endosc. 2018 Apr;87(4):1132-1137. doi: 10.1016/j.gie.2017.10.042. Epub 2017 Nov 8.

  PMID: 29128386 DERIVED

• Siiki A, Rinta-Kiikka I, Sand J, Laukkarinen J. Biodegradable biliary stent in the endoscopic treatment of cystic duct leak after cholecystectomy: the first case report and review of literature. J Laparoendosc Adv Surg Tech A. 2015 May;25(5):419-22. doi: 10.1089/lap.2015.0068. Epub 2015 Apr 8.

  PMID: 25853929 DERIVED

MeSH Terms

Conditions

Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Johanna Laukkarinen, Md, PhD

  Dept. of Gastroenterology and Alimentary Tract Surgery

  STUDY DIRECTOR

• Juhani Sand, Md, PhD

  Dept. of Gastroenterology and Alimentary Tract Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 2, 2015
• Study Start: May 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)