Crohn DiseaseDESTRESSNCT05009212
Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture
A study testing Endoscopic stricturotomy and Endoscopic balloon dilatation in people with Crohn Disease and Stricture; Bowel, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease, Stricture; Bowel, Endoscopy, Gastrointestinal
- What is being tested?
- Endoscopic stricturotomy and Endoscopic balloon dilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects had been diagnosed with CD for at least 3 months prior to screening, and the diagnosis of CD had clinical findings and endoscopic, imaging evidence, and was supported by histopathology reports
- Subject is in remission from CD (CDAI score < 150)
- Subjects had clinical findings of multiple fibrotic strictures of the bowel with obstruction and imaging evidence, and/or endoscopic evidence
- Subjects had ≤ 3 small bowel strictures (length < 5 cm) from duodenum to rectum and < 50 cm distance between strictures
- Study process prior to initiation, the subject or subject's legal representative (if applicable) signed and dated a written informed consent form or any required documentation of privacy authorization
- Female subjects who remained sexually and of childbearing potential with an ungerminated male partner, consented to adequate routine contraception throughout the study period starting with signing informed consent
Who cannot join
- At the initial screening visit, subject presented with enterocutaneous fistula, abdominal abscess, evidence of gastrointestinal bleeding
- Subjects were in active CD (CDAI score ≥ 150)
- The subject had inflammatory activity in the stenotic bowel (as judged by a combination of blood inflammatory indices, endoscopy, ultrasound and imaging)
- Presence of ileostomy, colostomy
- Subjects had a history or evidence of adenomatous colonic polyps that had not been resected or had a history or evidence of dysplasia of the colonic mucosa, including low - or high-grade dysplasia, and an undiagnosed type of dysplasia
- Subjects had suspected or confirmed ulcerative colitis, undiagnosed types of colitis, ischemic colitis, radiation enteritis, colitis associated diverticular disease, or microscopic colitis
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- Subjects had evidence of active infection during the screening period
- Subject has active tuberculosis
- Subjects with any defined inborn or acquired immunodeficiency (e.g., common various immunodeficiencies, human immunodeficiency virus [HIV] infection, organ transplantation)
- Subjects had a clinically significant infection (e.g., pneumonia, pyelonephritis) or an ongoing chronic infection within 30 days prior to screening
- The subject suffered from any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immune, endocrine / metabolic or other medical condition that, in the opinion of the investigator, would interfere with the outcome of the study or jeopardize the safety of the subject
- The subject's medical history included malignancy
- Subjects had abnormal laboratory results for any of the following during screening: hemoglobin < 5 g / dl; white blood cell (WBC) count < 3 ×10E9 / L; platelet count < 100 × 10E9 / L or > 1200 × 10E9 / L; alanine transaminase (ALT) or aspartate transaminase (AST) > 3 × upper limit of normal (ULN), and serum creatinine > 2 × ULN.
- Subjects were unable to attend all study visits or comply with study flow plans female subjects were pregnant prior to study enrollment, during study enrollment, or plan to donate eggs during these time periods
- Subjects were forced to consent to participate in the study
- Investigators considered the subject unsuitable for endoscopic treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Hongsheng Yang, MD, +86-20-38663423, hensonyang@foxmail.com
Qin Guo, MD
About this study
Official title: Randomized Trial of Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection.
Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The European Crohn's and Colitis Organisation (ECCO) guideline recommended that endoscopic balloon dilatation is suitable to treat short [<5 cm] strictures of the terminal ileum in CD. Recently, Lan et al. reported that endoscopic stricturotomy appeared to be more effective in treating CD patients with anastomotic stricture than endoscopic balloon dilatation.
However, there is no prospective clinical studies evaluating the efficacy and safety of endoscopic stricturotomy in the treatment of fibrostenotic Crohn's disease. The trial aims to compare the efficacy and safety of endoscopic stricturotomy with endoscopic balloon dilation in the treatment of small bowel stricture in patients with Crohn's Disease.
- Conditions
- Crohn Disease, Stricture; Bowel, Endoscopy, Gastrointestinal
- Being tested
- Endoscopic stricturotomy, Endoscopic balloon dilatation
- Medical subject headings
- Crohn Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic stricturotomyProcedure or surgery
Endoscopic stricturotomy for bowel stricture (<5 cm)
Endoscopic balloon dilatationProcedure or surgery
Endoscopic balloon dilatation for bowel stricture (<5 cm)
| Study group | Role | What they receive |
|---|---|---|
| ESt group | Experimental | Endoscopic stricturotomy Receives: Procedure: Endoscopic stricturotomy |
| EBD group | Active comparator | Endoscopic balloon dilatation Receives: Procedure: Endoscopic balloon dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery-free survival
Percentage of patients who do not receive surgical intervention for obstruction recurrence
Measured: 52 weeks
Secondary outcomes (8)
Endoscopic intervention-free survival
Percentage of patients who do not receive endoscopic intervention for obstruction recurrence
Measured: 52 weeks
Intervention-free survival
Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence
Measured: Week 52
Technical success rate
The passage of endoscope without resistance
Measured: Week 0
Obstructive score change
Obstructive score (scaling from 0 to 6, higher scores mean a worse outcome) change compared to baseline
Measured: Week 8, 16, 26, 52
Crohn's Disease Activity Index (CDAI) score change
Higher scores mean a worse outcome for CDAI score
Measured: Week 8, 16, 26, 52
Inflammatory Bowel Disease Questionnaire (IBDQ) score reduction
Higher scores mean a better outcome for IBDQ score
Measured: Week 8, 16, 26, 52
Adverse event rate
Percentage of adverse events
Measured: Week 52
Total cost
Total cost for intervention
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Aug 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin Guo, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009212
- Sponsor's protocol ID
- 2021ZSLYEC-243
- Acronym
- DESTRESS
- Status last verified
- Aug 2021
- First submitted
- 8 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture
- ClinicalTrials.gov ID
- NCT05009212
- Acronym / sponsor ID
- DESTRESS / 2021ZSLYEC-243
- Conditions
- Crohn Disease, Stricture; Bowel, Endoscopy, Gastrointestinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Aug 2021 (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.
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection.
Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The European Crohn's and Colitis Organisation (ECCO) guideline recommended that endoscopic balloon dilatation is suitable to treat short [<5 cm] strictures of the terminal ileum in CD. Recently, Lan et al. reported that endoscopic stricturotomy appeared to be more effective in treating CD patients with anastomotic stricture than endoscopic balloon dilatation.
However, there is no prospective clinical studies evaluating the efficacy and safety of endoscopic stricturotomy in the treatment of fibrostenotic Crohn's disease. The trial aims to compare the efficacy and safety of endoscopic stricturotomy with endoscopic balloon dilation in the treatment of small bowel stricture in patients with Crohn's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESt group | Experimental | Procedure: Endoscopic stricturotomyEndoscopic stricturotomy |
| EBD group | Active comparator | Procedure: Endoscopic balloon dilatationEndoscopic balloon dilatation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects had been diagnosed with CD for at least 3 months prior to screening, and the diagnosis of CD had clinical findings and endoscopic, imaging evidence, and was supported by histopathology reports
- Subject is in remission from CD (CDAI score < 150)
- Subjects had clinical findings of multiple fibrotic strictures of the bowel with obstruction and imaging evidence, and/or endoscopic evidence
- Subjects had ≤ 3 small bowel strictures (length < 5 cm) from duodenum to rectum and < 50 cm distance between strictures
- Study process prior to initiation, the subject or subject's legal representative (if applicable) signed and dated a written informed consent form or any required documentation of privacy authorization
Key exclusion criteria (16 listed)
- At the initial screening visit, subject presented with enterocutaneous fistula, abdominal abscess, evidence of gastrointestinal bleeding
- Subjects were in active CD (CDAI score ≥ 150)
- The subject had inflammatory activity in the stenotic bowel (as judged by a combination of blood inflammatory indices, endoscopy, ultrasound and imaging)
- Presence of ileostomy, colostomy
- Subjects had a history or evidence of adenomatous colonic polyps that had not been resected or had a history or evidence of dysplasia of the colonic mucosa, including low - or high-grade dysplasia, and an undiagnosed type of dysplasia
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 |
|---|---|---|
| Endoscopic stricturotomyEndoscopic stricturotomy for bowel stricture (<5 cm) | Procedure or surgery | ESt group |
| Endoscopic balloon dilatationEndoscopic balloon dilatation for bowel stricture (<5 cm) | Procedure or surgery | EBD group |
Primary outcome
Surgery-free survival
Time frame: 52 weeks
Percentage of patients who do not receive surgical intervention for obstruction recurrence
8 secondary outcomes
Endoscopic intervention-free survival
Time frame: 52 weeks
Intervention-free survival
Time frame: Week 52
Technical success rate
Time frame: Week 0
Obstructive score change
Time frame: Week 8, 16, 26, 52
Crohn's Disease Activity Index (CDAI) score change
Time frame: Week 8, 16, 26, 52
Inflammatory Bowel Disease Questionnaire (IBDQ) score reduction
Time frame: Week 8, 16, 26, 52
Adverse event rate
Time frame: Week 52
Total cost
Time frame: Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- 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.
Qin Guo, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic stricturotomy and Endoscopic balloon dilatation in people with Crohn Disease and Stricture; Bowel, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 6 inclusion and 16 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 17 Aug 2021. 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 China. 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 Qin Guo, MD (+86-20-38663423, guoq83@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery-free survival (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2021.