MedTrace Logo

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

NCT02353286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-05-14

No results posted yet for this study

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

Interventions

DEVICE

Endoscopic insertion of biodegradable biliary stent

Endoscopic insertion of biodegradable biliary stent

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Johanna Laukkarinen, Md, PhD · Dept. of Gastroenterology and Alimentary Tract Surgery

  • Juhani Sand, Md, PhD · Dept. of Gastroenterology and Alimentary Tract Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02353286 on ClinicalTrials.gov