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
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2013
CompletedFirst Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 7, 2025
CompletedMay 7, 2025
October 1, 2010
1.9 years
April 28, 2025
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dysfunction
Sign of dysfunction of biliary stenting (fever, pain, jaundice)
3 Months
Study Arms (2)
Conventional Stenting
ACTIVE COMPARATORStenting 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).
Winged Stent
EXPERIMENTALStenting 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Biliopancreatic disorder requiring plaxtic biliary stent therapy
- written informed consent
You may not qualify if:
- Pregnancy
- Breastfeeding
- Live Expectancy of less than one month
- Biliary drainage by metal stent or external drainage.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Leipzig Medical Center, Department of Gastroenterology
Leipzig, Saxony, 04103, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Albrecht Hoffmeister, Professor
University of Leipzig Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2025
First Posted
May 7, 2025
Study Start
June 1, 2011
Primary Completion
April 30, 2013
Study Completion
December 31, 2013
Last Updated
May 7, 2025
Record last verified: 2010-10
Data Sharing
- IPD Sharing
- Will not share