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

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.

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 Overview

• Status: Recruiting
• Conditions: Crohn Disease; Stricture; Bowel
• Intervention / Treatment: Procedure: Surgical resection; Procedure: Endoscopic stricturotomy; Procedure: Strictureplasty

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongsheng Yang, MD; Phone Number: +86-20-38663423; Email: hensonyang@foxmail.com
• Study Contact Backup: Name: Qin Guo, MD; Phone Number: +86-20-38663423; Email: guoq83@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510065
      • Recruiting
      • The Sixth Affiliated hospital, Sun Yat-sen University
      • Contact: Hongsheng Yang, MD; Phone Number: +86-20-38663423; Email: hensonyang@foxmail.com
      • Principal Investigator: Qin Guo, MD
      • Principal Investigator: Jia Ke, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRES group; Surgical resection plus endoscopic stricturotomy for multiple fibrous stenosis	Procedure: Surgical resection; Surgical resection of fibrostenotic area (>4cm); Procedure: Endoscopic stricturotomy; Endoscopic stricturotomy of fibrostenotic area (≤4cm)
Active Comparator: SRS group; Surgical resection plus strictureplasty for multiple fibrous stenosis	Procedure: Surgical resection; Surgical resection of fibrostenotic area (>4cm); Procedure: Strictureplasty; Strictureplasty of fibrostenotic area (≤4cm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention-free survival	Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery-free survival	Percentage of patients who do not receive surgical intervention for obstruction recurrence	52 weeks
Obstructive score reduction	Obstructive score reduction compared to baseline	Week 4、12、20、28、36、44、52
CDAI score reduction	CDAI score reduction compared to baseline	Week 4、12、20、28、36、44、52
IBDQ score reduction	IBDQ score reduction compared to baseline	Week 4、12、20、28、36、44、52
Adverse event rate	Percentage of adverse events	52 weeks
Total cost for intervention	Total cost for intervention	52 weeks

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2021ZSLYEC-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No