Prospective study on the efficacy of rifaximin in preventing cholangitis after self-expandable metallic stent placement in patients with distal malignant biliary obstruction

Ikezawa Kenji0 个研究点目标入组 30 人开始时间: 2022年2月10日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) The patient has distal biliary obstruction associated with an unresectable malignancy and requires endoscopic transpapillary biliary drainage.
•2) It is appropriate to place a self-expandable metallic stent across the papilla.
•3) First or second self-expandable metallic stent placement.
•4) No or improving cholangitis at the time of patient enrollment.
•5) Age is 20 years or older.
•6) Estimated survival more than three months
•7) ECOG performance status of 2 or below.
•8) Written informed consent.

•1) With gastrointestinal obstruction.
•2) Difficulty inserting endoscope.
•3) Post-gastrectomy reconstruction using methods other than Billroth I.
•4) With hilar biliary obstruction.
•5) Benign biliary obstruction.
•6) With active tuberculosis.
•7) Severe comorbidities [such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes(HbA1c>=10%)].
•8) Continuous systemic medication of corticosteroid or immunosuppressant.
•9) Rifaximin, kanamycin, and polymyxin B have been administered.
•10) The patient has already been enrolled in this clinical trial.
•11) Patients who are judged to be ineligible by investigators.

发起方

Ikezawa Kenji