Crohn DiseaseSURESTNCT04865484
Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease.
A study testing Surgical resection, Endoscopic stricturotomy and Strictureplasty 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 multi segmental 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
- What is being tested?
- Surgical resection, Endoscopic stricturotomy and Strictureplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2021to 31 Dec 2023
- 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 (abdominal pain with distension, decreased stool frequency and / or symptoms of nausea and vomiting) and imaging evidence (MRE and bowel color ultrasound suggested intestinal fibrosis with greater than 50% reduction in diameter and greater than 20% thickening of the bowel wall with dilation of the proximal bowel), and endoscopic evidence (endoscopy was unable to pass)
- Subjects had ≥ 2 small bowel strictures from duodenum to rectum and ≥ 20 cm maximum distance between coloanal and caudal 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
Show all 16Show fewer
- Subjects had evidence of active infection during the screening period
- Subject has active tuberculosis: chest X-ray performed within 3 months prior to week 0 results suggestive of suspected 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 or surgical 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, 510065
Hongsheng Yang, MD, +86-20-38663423, hensonyang@foxmail.com
Qin Guo, MD
About this study
Official title: Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease. Surgical Resection Plus Endoscopic Stricturotomy Versus Surgical Resection Plus Strictureplasty
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with multi segmental intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection.
Strictureplasty conserves bowel and minimizes the risk of developing short-bowel syndrome in the short-term and, probably, long-term. Strictureplasty has become an established surgical option in the management of obstructive Crohn's disease, especially for multiple short fibrous strictures. It is particularly suitable for patients at risk for short-bowel syndrome.
Read more
Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The 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 scientific evidence for determining the most appropriate treatment for multiple fibrosis stenosis. We designed a prospective randomized comparative study of the treatment of multisegmental fibrostenosing Crohn's disease (surgical resection plus endoscopic stricturotomy versus surgical resection plus strictureplasty).
- Conditions
- Crohn Disease, Stricture; Bowel
- Being tested
- Surgical resection, Endoscopic stricturotomy, Strictureplasty
- 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.
Surgical resectionProcedure or surgery
Surgical resection of fibrostenotic area (>4cm)
Endoscopic stricturotomyProcedure or surgery
Endoscopic stricturotomy of fibrostenotic area (≤4cm)
StrictureplastyProcedure or surgery
Strictureplasty of fibrostenotic area (≤4cm)
| Study group | Role | What they receive |
|---|---|---|
| SRES group | Experimental | Surgical resection plus endoscopic stricturotomy for multiple fibrous stenosis Receives: Procedure: Surgical resection; Procedure: Endoscopic stricturotomy |
| SRS group | Active comparator | Surgical resection plus strictureplasty for multiple fibrous stenosis Receives: Procedure: Surgical resection; Procedure: Strictureplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention-free survival
Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence
Measured: 52 weeks
Secondary outcomes (6)
Surgery-free survival
Percentage of patients who do not receive surgical intervention for obstruction recurrence
Measured: 52 weeks
Obstructive score reduction
Obstructive score reduction compared to baseline
Measured: Week 4、12、20、28、36、44、52
CDAI score reduction
CDAI score reduction compared to baseline
Measured: Week 4、12、20、28、36、44、52
IBDQ score reduction
IBDQ score reduction compared to baseline
Measured: Week 4、12、20、28、36、44、52
Adverse event rate
Percentage of adverse events
Measured: 52 weeks
Total cost for intervention
Total cost for intervention
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start12 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865484
- Sponsor's protocol ID
- 2021ZSLYEC-020
- Acronym
- SUREST
- Status last verified
- Mar 2021
- First submitted
- 27 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease. Surgical Resection Plus Endoscopic Stricturotomy Versus Surgical Resection Plus Strictureplasty
- ClinicalTrials.gov ID
- NCT04865484
- Acronym / sponsor ID
- SUREST / 2021ZSLYEC-020
- Conditions
- Crohn Disease, Stricture; Bowel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Apr 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 multi segmental intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection.
Strictureplasty conserves bowel and minimizes the risk of developing short-bowel syndrome in the short-term and, probably, long-term. Strictureplasty has become an established surgical option in the management of obstructive Crohn's disease, especially for multiple short fibrous strictures. It is particularly suitable for patients at risk for short-bowel syndrome.
Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The 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 scientific evidence for determining the most appropriate treatment for multiple fibrosis stenosis. We designed a prospective randomized comparative study of the treatment of multisegmental fibrostenosing Crohn's disease (surgical resection plus endoscopic stricturotomy versus surgical resection plus strictureplasty).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRES group | Experimental | Procedure: Surgical resection, Procedure: Endoscopic stricturotomySurgical resection plus endoscopic stricturotomy for multiple fibrous stenosis |
| SRS group | Active comparator | Procedure: Surgical resection, Procedure: StrictureplastySurgical resection plus strictureplasty for multiple fibrous stenosis |
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 (abdominal pain with distension, decreased stool frequency and / or symptoms of nausea and vomiting) and imaging evidence (MRE and bowel color ultrasound suggested intestinal fibrosis with greater than 50% reduction in diameter and greater than 20% thickening of the bowel wall with dilation of the proximal bowel), and endoscopic evidence (endoscopy was unable to pass)
- Subjects had ≥ 2 small bowel strictures from duodenum to rectum and ≥ 20 cm maximum distance between coloanal and caudal 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 |
|---|---|---|
| Surgical resectionSurgical resection of fibrostenotic area (>4cm) | Procedure or surgery | SRES group, SRS group |
| Endoscopic stricturotomyEndoscopic stricturotomy of fibrostenotic area (≤4cm) | Procedure or surgery | SRES group |
| StrictureplastyStrictureplasty of fibrostenotic area (≤4cm) | Procedure or surgery | SRS group |
Primary outcome
Intervention-free survival
Time frame: 52 weeks
Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence
6 secondary outcomes
Surgery-free survival
Time frame: 52 weeks
Obstructive score reduction
Time frame: Week 4、12、20、28、36、44、52
CDAI score reduction
Time frame: Week 4、12、20、28、36、44、52
IBDQ score reduction
Time frame: Week 4、12、20、28、36、44、52
Adverse event rate
Time frame: 52 weeks
Total cost for intervention
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical resection, Endoscopic stricturotomy and Strictureplasty 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 29 Apr 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?
Intervention-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 29 Apr 2021.