Comparison Between Winged Versus Traditional Plastic Stents for Biliary Drainage

NCT ID: NCT06960733

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-01
• Study Completion Date: 2013-12-31

Brief Summary

This study was randomized, controlled, blinded trial with a two-arm parallel-group design to directly compare the therapeutic outcomes of winged versus conventional stents in patients with benign or malignant biliopancreatic conditions requiring ERCP and subsequent insertion or replacement of plastic stents.

Detailed Description

Procedure The study was structured as a randomized, controlled trial using a two-arm parallel group design to compare different therapies (winged stent vs. conventional stent). Randomization was carried out in a 1:1 ratio using block randomization. Upon stent exchange, participants were switched to the alternate treatment group. Each subject was intended to receive both forms of therapy over the course of the treatment periods in a crossover design, with only the sequence of therapies being determined randomly (Figure 1).

The procedures were conducted using standard techniques. No additional steps, biopsies, or similar procedures were required. For the ERCPs carried out in the Endoscopy Department of the University Hospital Leipzig, Fujifilm video duodenoscopes were utilized

Data On the procedure date, we gathered essential baseline and procedural information including demographic data (age and gender), previous stent interventions, diagnostic imaging and laboratory results, specifics of the stent used (type, diameter, and length), the effectiveness of the stent insertion, and any associated complications.

Beyond standard care, follow-up was conducted at intervals of one week, one month, and two months post-intervention, utilizing a methodical questionnaire to monitor clinical progress and evaluate for any stent-related dysfunction."

Conditions

Biliary Obstruction; Bile Duct Stones; Biliary Tract Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional Stenting

Stenting of biliary tract by standard plastic stent. Change of stent-type at regular stent exchange after three months (from winged to standard and vice versae).

Group Type: ACTIVE_COMPARATOR

Winged plastic stent

Intervention Type: DEVICE

Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention winged stents were used.

Standard plastic stents

Intervention Type: DEVICE

Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention standard plastic stents were used.

Winged Stent

Stenting of biliary tract by use of winged-design stent. Change of stent-type at regular stent exchange after three months (from winged to standard and vice versae).

Group Type: EXPERIMENTAL

Winged plastic stent

Intervention Type: DEVICE

Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention winged stents were used.

Standard plastic stents

Intervention Type: DEVICE

Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention standard plastic stents were used.

Interventions

Winged plastic stent

Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention winged stents were used.

Intervention Type: DEVICE

Standard plastic stents

Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention standard plastic stents were used.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Biliopancreatic disorder requiring plaxtic biliary stent therapy
• written informed consent

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Live Expectancy of less than one month
• Biliary drainage by metal stent or external drainage.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albrecht Hoffmeister, Professor

Role: STUDY_CHAIR

University of Leipzig Medical Center

Locations

University of Leipzig Medical Center, Department of Gastroenterology

Leipzig, Saxony, Germany

Countries

Germany

Other Identifiers

Viaduct-ERCP

Identifier Type: -

Identifier Source: org_study_id