Comparison Between Winged Versus Traditional Plastic Stents for Biliary Drainage

Comparative Efficacy of Winged Versus Traditional Plastic Stents for Biliary Drainage in Benign and Malignant Obstructions: A Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Biliary Tract Cancer; Biliary Obstruction; Bile Duct Stones
• Intervention / Treatment: Device: Winged plastic stent; Device: Standard 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."

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxonia
    • Leipzig, Saxonia, Germany, 04103
      • University of Leipzig Medical Center, Department of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Device: 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.; 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.
Experimental: 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).	Device: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysfunction	Sign of dysfunction of biliary stenting (fever, pain, jaundice)	3 Months

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Study Chair: Albrecht Hoffmeister, Professor, University of Leipzig Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): April 30, 2013
• Study Completion (Actual): December 31, 2013

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: ERCP; Biliary obstruction; plastic stent; biliary stenting
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: Viaduct-ERCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No