NCT05634772

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

November 9, 2022

Last Update Submit

November 29, 2022

Conditions

Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To compare between dormia basket and extraction ballon regarding occurrence of re- obstruction

    4 weeks

Study Arms (2)

the efficacy of dormia basket in management of proximal stent migration

ACTIVE COMPARATOR
Device: dormia basket

the efficacy of extraction biliary balloon in management of proximal stent migration

ACTIVE COMPARATOR
Device: Extraction biliary ballon

Interventions

dormia basketDEVICE

Use of dormia basket in management of proximal stent migration

the efficacy of dormia basket in management of proximal stent migration
Extraction biliary ballonDEVICE

Use of extraction biliary balloon in management of proximal stent migration

the efficacy of extraction biliary balloon in management of proximal stent migration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults
  • both gender
  • Patients with biliary stenting following ERCP and who had signs of biliary obstruction.

You may not qualify if:

  • ERCP without stent insertion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Hussien Ahmed

Kafr ash Shaykh, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

November 9, 2022

First Posted

December 2, 2022

Study Start

December 1, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations

EG(1)