Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study
STRIDENT
1 other identifier
interventional
30
1 country
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 develop such strategies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedStudy Start
First participant enrolled
October 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedOctober 23, 2020
October 1, 2020
3.3 years
July 6, 2017
October 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).
3, 6 and 12 months
Improvement in imaging parameters
6 months
Improvement in endoscopic features
6 months
Avoidance of surgery
6 months
Improvement in patient reported outcomes (PROs)
6 months
- +2 more secondary outcomes
Study Arms (2)
Standard endoscopic therapy
ACTIVE COMPARATORSingle endoscopic dilatation
Intensive endoscopic therapy
EXPERIMENTAL3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty
Interventions
single endoscopic stricture dilatation
3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty
Eligibility Criteria
You may qualify if:
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Vincent's Hospital Melbourne
Melbourne, Victoria, 3065, Australia
Related Publications (1)
Schulberg JD, Hamilton AL, Wright EK, Holt BA, Sutherland TR, Ross AL, Vogrin S, Kamm MA. Repeated endoscopic dilation and needle-knife stricturotomy for Crohn's disease strictures. Gastrointest Endosc. 2025 Jan;101(1):202-206.e4. doi: 10.1016/j.gie.2024.09.031. Epub 2024 Sep 27.
PMID: 39343051DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open label study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Gastroenterology
Study Record Dates
First Submitted
July 6, 2017
First Posted
July 19, 2017
Study Start
October 9, 2017
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
October 23, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share