Endoscopic Stenting in Crohn Related Strictures

June 27, 2023 updated by: Per Hedenström, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Benign high-grade Crohn stricture

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stent
Procedure: Self-expandable metal stent
Endoscopic stenting of intestinal stricture related to Crohn´s disease
Active Comparator: Dilatation
Procedure: Balloon dilatation
Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Technical success rate
Time Frame: Peroperative
Peroperative
Adverse event rate
Time Frame: Within 7 days
Within 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical success rate
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Per-Ove Stotzer, Ass Prof, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project database VGR 95381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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