Endoscopic Stenting in Crohn Related Strictures

Sahlgrenska University Hospital

Status: Completed

Conditions: Intestinal Strictures Related to Crohn´s Disease

Treatments: Procedure: Self-expandable metal stent; Procedure: Balloon dilatation

Study type: Interventional

Funder types: Other

Identifiers

NCT04718493

Project database VGR 95381

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Benign high-grade Crohn stricture

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Stent

Experimental group

Treatment:

Procedure: Self-expandable metal stent

Dilatation

Active Comparator group

Treatment:

Procedure: Balloon dilatation