Clinical trial NCT03218202: Stricture Definition and Treatment (STRIDENT) Observational Study.
Official title: Stricture Definition and Treatment (STRIDENT) Observational Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Stricture; Colon
Keywords: Inflammatory Bowel Disease
Crohn Disease
Ulcerative Colitis
Intestinal stricture
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
Collaborators: name: Australasian Gastro Intestinal Research Foundation
First posted: 2017-07-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development of symptoms
timeFrame: 12 months
Secondary outcomes:
measure: Imaging features associated with development of symptoms (MRI).
timeFrame: 12 months
measure: Imaging features associated with development of symptoms (Intestinal Ultrasound).
timeFrame: 12 months
measure: Biochemical features associated with development of symptoms
timeFrame: 12 months
measure: Patient reported outcomes
timeFrame: 12 months
measure: Patient reported outcomes
timeFrame: 12 months
measure: Requirement for step up in drug therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
Study officials:
affiliation: St Vincent's Hospital Melbourne
name: Emily Wright, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital Melbourne
name: Bronte Holt, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital Melbourne
name: Michael Kamm, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References: