Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

Crohn Disease Clinical Trial

— STRIDENT  

Official title:

Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03222011
• Other study ID #: StVincentsMelbourneSTRIDENT2
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: February 2021

Study information

• Verified date: October 2020
• Source: St Vincent's Hospital Melbourne
• Contact: Julien Schulberg, MBBS
• Phone: +61 3 92312211
• Email: stridentstudy[@]svha.org.au
• Is FDA regulated: No
• Study type: Interventional

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 develop such strategies.

Description:

Prospective randomised controlled study. Patients with Crohn's Disease and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• 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.

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Stricture; Bowel

Intervention

Procedure:
• Standard (single) endoscopic stricture dilatation
single endoscopic stricture dilatation
• Intensive endoscopic stricture dilatation
3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

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	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)	6 months
Secondary	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)	3, 6 and 12 months
Secondary	Improvement in imaging parameters	MRI and intestinal ultrasound	6 months
Secondary	Improvement in endoscopic features	Increased patency of strictures on endoscopy	6 months
Secondary	Avoidance of surgery	Requirement for surgical resection of stricture	6 months
Secondary	Improvement in patient reported outcomes (PROs)	IBDQ	6 months
Secondary	Improvement in patient reported outcomes (PROs)	SF36	6 months
Secondary	Technical success of procedure	Successful endoscopic procedure	At time of procedure