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Status unknownNCT04865484SURESTUpdated Apr 29, 2021

Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease.

An interventional study of Surgical resection and Endoscopic stricturotomy in Crohn Disease and Stricture; Bowel, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-29.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Crohn Disease
  • Stricture; Bowel

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 120 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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
  2. Subject is in remission from CD (CDAI score \< 150)
  3. 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)
  4. Subjects had ≥ 2 small bowel strictures from duodenum to rectum and ≥ 20 cm maximum distance between coloanal and caudal strictures
  5. 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
  6. 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

Exclusion criteria

Exclusion Criteria:

  1. At the initial screening visit, subject presented with enterocutaneous fistula, abdominal abscess, evidence of gastrointestinal bleeding
  2. Subjects were in active CD (CDAI score ≥ 150)
  3. The subject had inflammatory activity in the stenotic bowel (as judged by a combination of blood inflammatory indices, endoscopy, ultrasound and imaging)
  4. Presence of ileostomy, colostomy
  5. 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
  6. Subjects had suspected or confirmed ulcerative colitis, undiagnosed types of colitis, ischemic colitis, radiation enteritis, colitis associated diverticular disease, or microscopic colitis
  7. Subjects had evidence of active infection during the screening period
  8. Subject has active tuberculosis: chest X-ray performed within 3 months prior to week 0 results suggestive of suspected tuberculosis
  9. Subjects with any defined inborn or acquired immunodeficiency (e.g., common various immunodeficiencies, human immunodeficiency virus [HIV] infection, organ transplantation)
  10. Subjects had a clinically significant infection (e.g., pneumonia, pyelonephritis) or an ongoing chronic infection within 30 days prior to screening
  11. 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
  12. The subject's medical history included malignancy
  13. 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.
  14. 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
  15. Subjects were forced to consent to participate in the study
  16. Investigators considered the subject unsuitable for endoscopic or surgical treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    SRES group

    Surgical resection plus endoscopic stricturotomy for multiple fibrous stenosis

    Procedure: Surgical resection · Procedure: Endoscopic stricturotomy

  • Active comparator
    SRS group

    Surgical resection plus strictureplasty for multiple fibrous stenosis

    Procedure: Surgical resection · Procedure: Strictureplasty

Interventions

  • ProcedureSurgical resection

    Surgical resection of fibrostenotic area (\>4cm)

  • ProcedureEndoscopic stricturotomy

    Endoscopic stricturotomy of fibrostenotic area (≤4cm)

  • ProcedureStrictureplasty

    Strictureplasty of fibrostenotic area (≤4cm)

06

What researchers measure

Primary outcomes

  1. Intervention-free survival

    Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence

    Time frame: 52 weeks

Secondary outcomes

  1. Surgery-free survival

    Percentage of patients who do not receive surgical intervention for obstruction recurrence

    Time frame: 52 weeks

  2. Obstructive score reduction

    Obstructive score reduction compared to baseline

    Time frame: Week 4、12、20、28、36、44、52

  3. CDAI score reduction

    CDAI score reduction compared to baseline

    Time frame: Week 4、12、20、28、36、44、52

  4. IBDQ score reduction

    IBDQ score reduction compared to baseline

    Time frame: Week 4、12、20、28、36、44、52

  5. Adverse event rate

    Percentage of adverse events

    Time frame: 52 weeks

  6. Total cost for intervention

    Total cost for intervention

    Time frame: 52 weeks

07

Study locations

1 of 1 sites recruiting
  • The Sixth Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510065, China
    • Hongsheng Yang, MD · Contact · hensonyang@foxmail.com · +86-20-38663423
    • Qin Guo, MD · Principal investigator
    • Jia Ke, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04865484
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible party
Sponsor
First posted
Apr 29, 2021
Start date
Mar 12, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 29, 2021

Study contacts

Qin Guo, MD
Contact
guoq83@mail.sysu.edu.cn
+86-20-38663423
Hongsheng Yang, MD
Contact
hensonyang@foxmail.com
+86-20-38663423

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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