Endoscopic Stenting in Crohn Related Strictures

Not Applicable

Completed

• Conditions: Intestinal Strictures Related to Crohn´s Disease
• Interventions: Procedure: Balloon dilatation; Procedure: Self-expandable metal stent

• Registration Number: NCT04718493
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2016-12
• Study Completion: 2020-05
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Benign high-grade Crohn stricture

Exclusion Criteria

• Unwillingness to participate
• Planned surgery
• High risk for bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dilatation	Balloon dilatation	-
Stent	Self-expandable metal stent	-

Primary Outcome Measures

Name	Time	Method
Technical success rate	Peroperative
Adverse event rate	Within 7 days

Secondary Outcome Measures

Name	Time	Method
Clinical success rate	24 months