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Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study (STRIDENT)

Primary Purpose

Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Standard (single) endoscopic stricture dilatation
Intensive endoscopic stricture dilatation
Sponsored by
St Vincent's Hospital Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Vincent's Hospital MelbourneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard endoscopic therapy

Intensive endoscopic therapy

Arm Description

Single endoscopic dilatation

3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2017
Last Updated
October 22, 2020
Sponsor
St Vincent's Hospital Melbourne
Collaborators
Australasian Gastro Intestinal Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03222011
Brief Title
Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study
Acronym
STRIDENT
Official Title
Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Vincent's Hospital Melbourne
Collaborators
Australasian Gastro Intestinal Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
Keywords
Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
None (Open Label)
Masking Description
Open label study
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard endoscopic therapy
Arm Type
Active Comparator
Arm Description
Single endoscopic dilatation
Arm Title
Intensive endoscopic therapy
Arm Type
Experimental
Arm Description
3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty
Intervention Type
Procedure
Intervention Name(s)
Standard (single) endoscopic stricture dilatation
Intervention Description
single endoscopic stricture dilatation
Intervention Type
Procedure
Intervention Name(s)
Intensive endoscopic stricture dilatation
Intervention Description
3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty
Primary Outcome Measure Information:
Title
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).
Description
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)
Time Frame
3, 6 and 12 months
Title
Improvement in imaging parameters
Description
MRI and intestinal ultrasound
Time Frame
6 months
Title
Improvement in endoscopic features
Description
Increased patency of strictures on endoscopy
Time Frame
6 months
Title
Avoidance of surgery
Description
Requirement for surgical resection of stricture
Time Frame
6 months
Title
Improvement in patient reported outcomes (PROs)
Description
IBDQ
Time Frame
6 months
Title
Improvement in patient reported outcomes (PROs)
Description
SF36
Time Frame
6 months
Title
Technical success of procedure
Description
Successful endoscopic procedure
Time Frame
At time of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Schulberg, MBBS
Phone
+61 3 92312211
Email
stridentstudy@svha.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Hamilton, PhD
Phone
+61 3 92312211
Email
stridentstudy@svha.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Wright, MBBS PhD
Organizational Affiliation
St Vincent's Hospital Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bronte Holt, MBBS PhD
Organizational Affiliation
St Vincent's Hospital Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Kamm, MBBS PhD
Organizational Affiliation
St Vincent's Hospital Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Schulberg, MBBS
First Name & Middle Initial & Last Name & Degree
Amy Hamilton

12. IPD Sharing Statement

Plan to Share IPD
No

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Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

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