Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents

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

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

Study Overview

• Status: Completed
• Conditions: Biliary Obstruction
• Intervention / Treatment: Device: dormia basket; Device: Extraction biliary ballon

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt
    • Mohamed Hussien Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the efficacy of dormia basket in management of proximal stent migration	Device: dormia basket; Use of dormia basket in management of proximal stent migration
Active Comparator: the efficacy of extraction biliary balloon in management of proximal stent migration	Device: Extraction biliary ballon; Use of extraction biliary balloon in management of proximal stent migration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare between dormia basket and extraction ballon regarding occurrence of re- obstruction	Re-obstruction was measured by serum bilirubin level	4 weeks

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Kafrelsheikh U , medicine

Drug and device information, study documents

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