Stricture Definition and Treatment (STRIDENT) Observational Study.

Ulcerative Colitis Clinical Trial

— STRIDENT  

Official title:

Stricture Definition and Treatment (STRIDENT) Observational Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03218202
• Other study ID #: SVHMelbourneSTRIDENT3
• Status: Terminated
• Start date: October 9, 2017
• Est. completion date: August 29, 2019

Study information

• Verified date: August 2019
• Source: St Vincent's Hospital Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Constriction, Pathologic
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Stricture; Colon
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital Melbourne	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
St Vincent's Hospital Melbourne	Australasian Gastro Intestinal Research Foundation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of symptoms	Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy).	12 months
Secondary	Imaging features associated with development of symptoms (MRI).	MaRIA	12 months
Secondary	Imaging features associated with development of symptoms (Intestinal Ultrasound).	Limberg's score	12 months
Secondary	Biochemical features associated with development of symptoms	CRP and calprotectin	12 months
Secondary	Patient reported outcomes	SF36	12 months
Secondary	Patient reported outcomes	IBDQ	12 months
Secondary	Requirement for step up in drug therapy	Need for additional drug therapy due to development of symptoms	12 months