Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

Not Applicable

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Stricture; Bowel
• Interventions: Procedure: Standard (single) endoscopic stricture dilatation; Procedure: Intensive endoscopic stricture dilatation

• Registration Number: NCT03222011
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-19
• Study Start: 2017-10-09
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard endoscopic therapy	Standard (single) endoscopic stricture dilatation	Single endoscopic dilatation
Intensive endoscopic therapy	Intensive endoscopic stricture dilatation	3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

Primary Outcome Measures

Name	Time	Method
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Improvement in patient reported outcomes (PROs)	6 months	SF36
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).	3, 6 and 12 months	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)
Improvement in imaging parameters	6 months	MRI and intestinal ultrasound
Improvement in endoscopic features	6 months	Increased patency of strictures on endoscopy
Avoidance of surgery	6 months	Requirement for surgical resection of stricture
Technical success of procedure	At time of procedure	Successful endoscopic procedure

Trial Locations

Locations (1)

St. Vincent's Hospital Melbourne; 🇦🇺 Melbourne, Victoria, Australia