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NCT05634772 Clinical Trial

Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents

Biliary Obstruction Clinical Trial

Official title:
Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents:A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05634772
Other study ID # Kafrelsheikh U , medicine
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date December 30, 2020

Study information
Verified date November 2022
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial

Description:

Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial The study aims to evaluate the efficacy of dormia basket versus extraction biliary balloon in management of proximal stent migration

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adults 2. both gender 3. Patients with biliary stenting following ERCP and who had signs of biliary obstruction. Exclusion Criteria: ERCP without stent insertion.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• dormia basket
Use of dormia basket in management of proximal stent migration
• Extraction biliary ballon
Use of extraction biliary balloon in management of proximal stent migration

Locations
Country Name City State
Egypt Mohamed Hussien Ahmed Kafr Ash Shaykh

Sponsors (1)
Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other To compare between dormia basket and extraction ballon regarding occurrence of re- obstruction Re-obstruction was measured by serum bilirubin level 4 weeks
Primary To compare between dormia basket and extraction ballon in management of proximally migrated biliary stents regarding operative time (min) Operative time was measured by minutes 4 weeks
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