Stricture Definition and Treatment (STRIDENT) Observational Study.

NCT03218202 | Terminated DMC

• 1 other identifier: SVHMelbourneSTRIDENT3
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Stricture; Colon

Keywords

Inflammatory Bowel Disease; Crohn Disease; Ulcerative Colitis; Intestinal stricture

Outcome Measures

Primary Outcomes (1)

• Development of symptoms

  Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy).

  12 months

Secondary Outcomes (6)

• Imaging features associated with development of symptoms (MRI).

  12 months

• Imaging features associated with development of symptoms (Intestinal Ultrasound).

  12 months

• Biochemical features associated with development of symptoms

  12 months

• Patient reported outcomes

  12 months

• Patient reported outcomes

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis) without symptoms who are incidentally found to have a stricture on CT, MRI or endoscopy.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead
• Australasian Gastro Intestinal Research Foundation: collaborator

Study Sites (1)

St. Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Standard blood tests. Tests for Single Nucleotide Polymorphisms. Stool testing, Tissue Sampling.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily Wright, MBBS PhD

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

• Bronte Holt, MBBS PhD

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

• Michael Kamm, MBBS PhD

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 14, 2017
• Study Start: October 9, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

AU (1)