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

NCT04865484 | Unknown

• 1 other identifier: 2021ZSLYEC-020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Crohn Disease; Stricture; Bowel

Outcome Measures

Primary Outcomes (1)

• Intervention-free survival

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

  52 weeks

Secondary Outcomes (6)

• Surgery-free survival

  52 weeks

• Obstructive score reduction

  Week 4、12、20、28、36、44、52

• CDAI score reduction

  Week 4、12、20、28、36、44、52

• IBDQ score reduction

  Week 4、12、20、28、36、44、52

• Adverse event rate

  52 weeks

Study Arms (2)

SRES group

EXPERIMENTAL

Surgical resection plus endoscopic stricturotomy for multiple fibrous stenosis

Procedure: Surgical resection; Procedure: Endoscopic stricturotomy

SRS group

ACTIVE COMPARATOR

Surgical resection plus strictureplasty for multiple fibrous stenosis

Procedure: Surgical resection; Procedure: Strictureplasty

Interventions

Surgical resection PROCEDURE

Surgical resection of fibrostenotic area (\>4cm)

SRES group; SRS group

Endoscopic stricturotomy PROCEDURE

Endoscopic stricturotomy of fibrostenotic area (≤4cm)

SRES group

Strictureplasty PROCEDURE

Strictureplasty of fibrostenotic area (≤4cm)

SRS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510065, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qin Guo, MD

CONTACT

+86-20-38663423; guoq83@mail.sysu.edu.cn

Hongsheng Yang, MD

CONTACT

+86-20-38663423; hensonyang@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: March 12, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 29, 2021

Record last verified: 2021-03

Locations

CN (1)