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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Stricture; Bowel
• Intervention / Treatment: Procedure: Standard (single) endoscopic stricture dilatation; Procedure: Intensive endoscopic stricture dilatation

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3065
      • Recruiting
      • St. Vincent's Hospital Melbourne
      • Contact: Julien Schulberg, MBBS
      • Contact: Amy Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St Vincent's Hospital Melbourne
• Collaborators: Australasian Gastro Intestinal Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; Crohn Disease; Intestinal stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Crohn Disease; Constriction, Pathologic; Intestinal Diseases
• Other Study ID Numbers: StVincentsMelbourneSTRIDENT2

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
• product manufactured in and exported from the U.S.: No