Stricture Definition and Treatment (STRIDENT) Observational Study.

Terminated

• Conditions: Ulcerative Colitis; Crohn Disease; Inflammatory Bowel Diseases; Stricture; Colon

• Registration Number: NCT03218202
• 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 determine biochemical and imaging features associated with the development of strictures and in related STRIDENT studies develop strategies for treatment.

Detailed Description

Patients with asymptomatic Crohn's disease strictures will be followed prospectively for 12 months using imaging (including MRI/intestinal ultrasound) and biochemical analyses (including CRP/calprotectin). Patient's with symptomatic or asymptomatic ulcerative colitis related strictures will be followed similarly. Risk factors for progression of strictures and development of symptoms will be identified.

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2017-10-09
• Status Verified: 2019-08
• Primary Completion: 2019-08-29
• Study Completion: 2019-08-29
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy but without associated symptoms

Exclusion Criteria

• 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
• Inability to undergo MRI small bowel due to a contraindication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of symptoms	12 months	Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy).

Secondary Outcome Measures

Name	Time	Method
Imaging features associated with development of symptoms (Intestinal Ultrasound).	12 months	Limberg's score
Imaging features associated with development of symptoms (MRI).	12 months	MaRIA
Biochemical features associated with development of symptoms	12 months	CRP and calprotectin
Patient reported outcomes	12 months	IBDQ
Requirement for step up in drug therapy	12 months	Need for additional drug therapy due to development of symptoms

Trial Locations

Locations (1)

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