Back to resultsEndoscopic Stenting in Crohn Related Strictures
Primary Purpose
Intestinal Strictures Related to Crohn´s Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-expandable metal stent
Balloon dilatation
Sponsored by
About this trial
This is an interventional treatment trial for Intestinal Strictures Related to Crohn´s Disease
Eligibility Criteria
Inclusion Criteria:
- Benign high-grade Crohn stricture
Exclusion Criteria:
- Unwillingness to participate
- Planned surgery
- High risk for bleeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stent
Dilatation
Arm Description
Outcomes
Primary Outcome Measures
Technical success rate
Adverse event rate
Secondary Outcome Measures
Clinical success rate
Full Information
NCT ID
NCT04718493
First Posted
January 18, 2021
Last Updated
June 27, 2023
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04718493
Brief Title
Endoscopic Stenting in Crohn Related Strictures
Official Title
Endoscopic Stenting in Crohn Related Strictures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Strictures Related to Crohn´s Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stent
Arm Type
Experimental
Arm Title
Dilatation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Self-expandable metal stent
Intervention Description
Endoscopic stenting of intestinal stricture related to Crohn´s disease
Intervention Type
Procedure
Intervention Name(s)
Balloon dilatation
Intervention Description
Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease
Primary Outcome Measure Information:
Title
Technical success rate
Time Frame
Peroperative
Title
Adverse event rate
Time Frame
Within 7 days
Secondary Outcome Measure Information:
Title
Clinical success rate
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Benign high-grade Crohn stricture
Exclusion Criteria:
Unwillingness to participate
Planned surgery
High risk for bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per-Ove Stotzer, Ass Prof
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33722805
Citation
Hedenstrom P, Stotzer PO. Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study. BMJ Open Gastroenterol. 2021 Mar;8(1):e000612. doi: 10.1136/bmjgast-2021-000612.
Results Reference
derived
Learn more about this trial
Endoscopic Stenting in Crohn Related Strictures
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