Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

N/AUnknownNCT03222011

St Vincent's Hospital Melbourne30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn Disease Inflammatory Bowel Diseases Stricture; Bowel

Interventions

Standard (single) endoscopic stricture dilatationPROCEDURE

single endoscopic stricture dilatation

Intensive endoscopic stricture dilatationPROCEDURE

3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 6 months

Secondary Outcomes

Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).

Time frame: 3, 6 and 12 months

Improvement in imaging parameters

MRI and intestinal ultrasound

Time frame: 6 months

Improvement in endoscopic features

Increased patency of strictures on endoscopy

Time frame: 6 months

Avoidance of surgery

Requirement for surgical resection of stricture

Time frame: 6 months

Improvement in patient reported outcomes (PROs)

IBDQ

Time frame: 6 months

Improvement in patient reported outcomes (PROs)

SF36

Time frame: 6 months

Technical success of procedure

Successful endoscopic procedure

Central Contacts

Julien Schulberg, MBBS

CONTACT

+61 3 92312211 stridentstudy@svha.org.au

Amy Hamilton, PhD

CONTACT

+61 3 92312211 stridentstudy@svha.org.au

Data from ClinicalTrials.gov

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