Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

Study Overview
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Brief Summary
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Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

Detailed Description
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Prospective randomised controlled study. Patients with Crohn's Disease and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.

Official Title
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Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

Conditions
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Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel

Intervention / Treatment
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* Procedure: Standard (single) endoscopic stricture dilatation
* Procedure: Intensive endoscopic stricture dilatation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy. Exclusion Criteria: Acute bowel obstruction requiring urgent surgical intervention Deemed by treating physician to have high risk of acute bowel obstruction Concurrent active perianal sepsis Internal fistulising disease in association with strictures (entero-enteric stulas) Low rectal or anal strictures Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies Patients for whom endoscopy is not suitable due to co-morbidities or clinical state Inability to give informed consent Suspected perforation of the gastrointestinal tract Pregnancy Inability to undergo MRI small bowel due to a contraindication.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard endoscopic therapy<br>Single endoscopic dilatation | Procedure: Standard (single) endoscopic stricture dilatation<br>* single endoscopic stricture dilatation<br>|
| Experimental: Intensive endoscopic therapy<br>3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty | Procedure: Intensive endoscopic stricture dilatation<br>* 3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS). | The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (no pain, mild, moderate, severe, unbearable) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS). | The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (no pain, mild, moderate, severe, unbearable) | 3, 6 and 12 months | 
| Improvement in imaging parameters | MRI and intestinal ultrasound | 6 months | 
| Improvement in endoscopic features | Increased patency of strictures on endoscopy | 6 months | 
| Avoidance of surgery | Requirement for surgical resection of stricture | 6 months | 
| Improvement in patient reported outcomes (PROs) | IBDQ | 6 months | 
| Improvement in patient reported outcomes (PROs) | SF36 | 6 months | 
| Technical success of procedure | Successful endoscopic procedure | At time of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture