Endoscopic Stenting in Crohn Related Strictures

Intestinal Strictures Related to Crohn´s Disease Clinical Trial

Official title:

Endoscopic Stenting in Crohn Related Strictures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718493
• Other study ID #: Project database VGR 95381
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: May 2020

Study information

• Verified date: June 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Benign high-grade Crohn stricture

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Crohn Disease
• Intestinal Strictures Related to Crohn´s Disease

Intervention

Procedure:
• Self-expandable metal stent
Endoscopic stenting of intestinal stricture related to Crohn´s disease
• Balloon dilatation
Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success rate		Peroperative
Primary	Adverse event rate		Within 7 days
Secondary	Clinical success rate		24 months