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Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis (OGF1707)

Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis (OGF1707)

17

Patients with Crohn's disease complicated with intestinal stenosis attending Osaka University Hospital who are scheduled for endoscopic balloon dilatation and have given written consent.

The expected number of patients was 15, and consent was obtained for 17 patients: one did not undergo balloon dilation and one did not consent to oral budesonide after balloon dilation. A total of 15 patients completed the study.

There was one case in which insomnia occurred after taking the drug and the drug was discontinued, but the symptoms quickly disappeared after the drug was stopped.

The primary endpoint (safety at 12 weeks after balloon dilation) and the secondary endpoint (safety at 52 weeks after balloon dilation) were considered to be safe, as there were no cases of serious complications such as perforation, bleeding, or infection. The restenosis rate at 52 weeks after EBD was 85.7%. The restenosis rate at 52 weeks after EBD was 85.7%, and the redilatation rate was 78.6%. Although it is difficult to compare the results because of the lack of previous reports, there were some cases in which dilation was avoided, suggesting that the procedure may have been effective.

Budesonide after endoscopic balloon dilation in patients with Crohn's disease complicated by intestinal stenosis can be safely performed and may improve restenosis.

Sept. 02, 2025

No

We have no plan.

https://jrct.mhlw.go.jp/latest-detail/jRCT1051190043

Takehara Tetsuo

Osaka University Hospital

2-15, Yamadaoka, Suita, Osaka, Japan

takehara@gh.med.osaka-u.ac.jp

Shinzaki Shinichiro

Osaka University Hospital

2-15, Yamadaoka, Suita, Osaka, Japan

+81-6-6879-3621

shinzaki@gh.med.osaka-u.ac.jp

Complete

Mar. 30, 2018

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Mild to moderate active Crohn's disease patients with written consent at Osaka University Hospital and affiliated hospitals, who have intestinal stenosis and are scheduled or recieved endoscopic balloon dilation (EBD), are included.

Patients with more than 5 centimeters long stenosis
Patients with internal or external fistula
Patients with active infection, including abscess
Patients with oral treatment of antithrombotic drugs or low platelet that counts less than 50000 per microlitter
Patients with cancer
Patients under 20 years old
Patients with severy bad general condition
Patients who are administered steroids within 4 weeks
Patients who are judged inapropriate by doctors

Both

Crohn's disease

At the time of resumption of food after endoscopic balloon dilation, patients receive 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.

Safety within 12 weeks after EBD

Safety within 52 weeks after EBD
Rate of non-intestinal resection, non-reEBD and non-hospitalization
Rate of non-restenosis at 52 weeks after EBD

+81-6-6210-8324

April. 10, 2019

none