Crohn DiseaseSTRIDENTNCT03222011
Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study
A study testing Standard (single) endoscopic stricture dilatation and Intensive endoscopic stricture dilatation in people with Crohn Disease and Inflammatory Bowel Diseases, run by St Vincent's Hospital Melbourne at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
- What is being tested?
- Standard (single) endoscopic stricture dilatation and Intensive endoscopic stricture dilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Oct 2017to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Julien Schulberg, MBBS
Amy Hamilton
About this study
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.
Read the 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.
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
- Being tested
- Standard (single) endoscopic stricture dilatation, Intensive endoscopic stricture dilatation
- Keywords
- Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard (single) endoscopic stricture dilatationProcedure or surgery
single endoscopic stricture dilatation
Intensive endoscopic stricture dilatationProcedure or surgery
3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty
| Study group | Role | What they receive |
|---|---|---|
| Standard endoscopic therapy | Active comparator | Single endoscopic dilatation Receives: Procedure: Standard (single) endoscopic stricture dilatation |
| Intensive endoscopic therapy | Experimental | 3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty Receives: Procedure: Intensive endoscopic stricture dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (7)
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)
Measured: 3, 6 and 12 months
Improvement in imaging parameters
MRI and intestinal ultrasound
Measured: 6 months
Improvement in endoscopic features
Increased patency of strictures on endoscopy
Measured: 6 months
Avoidance of surgery
Requirement for surgical resection of stricture
Measured: 6 months
Improvement in patient reported outcomes (PROs)
IBDQ
Measured: 6 months
Improvement in patient reported outcomes (PROs)
SF36
Measured: 6 months
Technical success of procedure
Successful endoscopic procedure
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start9 Oct 2017
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Gastro Intestinal Research Foundation
- Responsible party
- Principal investigator, Michael Kamm, St Vincent's Hospital Melbourne
- Investigators
- Emily Wright, MBBS PhD, Principal investigator, St Vincent's Hospital MelbourneBronte Holt, MBBS PhD, Principal investigator, St Vincent's Hospital MelbourneMichael Kamm, MBBS PhD, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222011
- Sponsor's protocol ID
- StVincentsMelbourneSTRIDENT2
- Acronym
- STRIDENT
- Status last verified
- Oct 2020
- First submitted
- 6 Jul 2017
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39343051
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study
- ClinicalTrials.gov ID
- NCT03222011
- Acronym / sponsor ID
- STRIDENT / StVincentsMelbourneSTRIDENT2
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
- Keywords
- Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Collaborators
- Australasian Gastro Intestinal Research Foundation
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard endoscopic therapy | Active comparator | Procedure: Standard (single) endoscopic stricture dilatationSingle endoscopic dilatation |
| Intensive endoscopic therapy | Experimental | Procedure: Intensive endoscopic stricture dilatation3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard (single) endoscopic stricture dilatationsingle endoscopic stricture dilatation | Procedure or surgery | Standard endoscopic therapy |
| Intensive endoscopic stricture dilatation3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty | Procedure or surgery | Intensive endoscopic therapy |
Primary outcome
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).
Time frame: 6 months
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)
7 secondary outcomes
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).
Time frame: 3, 6 and 12 months
Improvement in imaging parameters
Time frame: 6 months
Improvement in endoscopic features
Time frame: 6 months
Avoidance of surgery
Time frame: 6 months
Improvement in patient reported outcomes (PROs)
Time frame: 6 months
Improvement in patient reported outcomes (PROs)
Time frame: 6 months
Technical success of procedure
Time frame: At time of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 39343051Schulberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Wright, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
Bronte Holt, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
Michael Kamm, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard (single) endoscopic stricture dilatation and Intensive endoscopic stricture dilatation in people with Crohn Disease and Inflammatory Bowel Diseases, run by St Vincent's Hospital Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Schulberg, MBBS (+61 3 92312211, stridentstudy@svha.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.