Safety and utility of endoscopic balloon dilation in small intestinal strictures of Crohn's disease

JRCT ID: jRCT1030220093

Registered date:28/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Crohn's disease
• Date of first enrollment: 28/05/2022
• Target sample size: 40
• Study type: Observational

Outcome(s)

• Primary Outcome: Improvement of stricture inner diameter during follow-up after balloon dilation
• Secondary Outcome: Adverse events associated with balloon dilation, avoidance rate of re-balloon dilation, avoidance rate of surgical treatment, improvement rate of stricture symptoms, QOL questionnaire for inflammatory bowel disease (SIBDQ), Leucine-rich alpha 2 glycoprotein (LRG), fecal calprotectin

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

-Cases with endoscopic balloon dilation planned for Crohn's disease patients with small intestinal strictures who have been hospitalized or visited from the date of approval completion to December 31, 2024, in the department of Gastroenterology, Jichi Medical University Hospital.
-Regardless of gender or nationality

Exclude criteria

-Cases that refused to participate in this study
-Cases in which the information in the medical records (age at the time of diagnosis, treatment details, etc.) is inadequate.
-Patients with only anastomotic stricture
-Cases with long stricture of 5 cm or more, fistula, fissure, abscess, deep ulcer, high degree of adhesion, flexion, and high risk of bleeding and perforation associated with the procedure, which are contraindicated for endoscopic balloon dilation,
-Cases that the principal investigator deems inappropriate as a research subject

Related Information

• Primary Sponsor: Yano Tomonori