Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture

NCT05009212 | Unknown

• 1 other identifier: 2021ZSLYEC-243
• Study Type: interventional
• Target: 96
• 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 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

Outcome Measures

Primary Outcomes (1)

• Surgery-free survival

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

  52 weeks

Secondary Outcomes (8)

• Endoscopic intervention-free survival

  52 weeks

• Intervention-free survival

  Week 52

• Technical success rate

  Week 0

• Obstructive score change

  Week 8, 16, 26, 52

• Crohn's Disease Activity Index (CDAI) score change

  Week 8, 16, 26, 52

Study Arms (2)

ESt group

EXPERIMENTAL

Endoscopic stricturotomy

Procedure: Endoscopic stricturotomy

EBD group

ACTIVE COMPARATOR

Endoscopic balloon dilatation

Procedure: Endoscopic balloon dilatation

Interventions

Endoscopic stricturotomy PROCEDURE

Endoscopic stricturotomy for bowel stricture (\<5 cm)

ESt group

Endoscopic balloon dilatation PROCEDURE

Endoscopic balloon dilatation for bowel stricture (\<5 cm)

EBD 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 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

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
• 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, 510000, 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

Study Officials

• Qin Guo, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

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: August 8, 2021
• First Posted: August 17, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)