Clinical trial NCT05009212: Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture
Official title: Randomized Trial of Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Stricture; Bowel
Endoscopy, Gastrointestinal
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 and imaging evidence, and/or endoscopic evidence
4. Subjects had ≤ 3 small bowel strictures (length \< 5 cm) from duodenum to rectum and \< 50 cm distance between 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
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 treatment

Primary outcomes:
measure: Surgery-free survival
timeFrame: 52 weeks
Secondary outcomes:
measure: Endoscopic intervention-free survival
timeFrame: 52 weeks
measure: Intervention-free survival
timeFrame: Week 52
measure: Technical success rate
timeFrame: Week 0
measure: Obstructive score change
timeFrame: Week 8, 16, 26, 52
measure: Crohn's Disease Activity Index (CDAI) score change
timeFrame: Week 8, 16, 26, 52
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) score reduction
timeFrame: Week 8, 16, 26, 52
measure: Adverse event rate
timeFrame: Week 52
measure: Total cost
timeFrame: Week 52
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Qin Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: