Prospective study on suppression of cholangitis using rifaximin after SEMS placement for distal malignant biliary obstruction

JRCT ID: jRCTs051210173

Registered date:10/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: malignant tumor
• Date of first enrollment: 06/04/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Oral rifaximin administration after placement of self-expandable metallic stent for distal malignant biliary obstruction.

Outcome(s)

• Primary Outcome: Incidence of cholangitis
• Secondary Outcome: Time to onset of cholangitis, recurrent biliary obstruction (RBO) rate, details of RBO, time to recurrent biliary obstruction (TRBO), re-intervention rate, rate of adverse events with rifaximin, rate of serious adverse events, overall survival, 1 year survival rate, continuation rate of chemotherapy, bile culture results and antimicrobial susceptibility test results at the time of cholangitis.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Ikezawa Kenji
• Secondary Sponsor: Ohkawa Kazuyoshi,Kai Yugo
• Source(s) of Monetary Support: ASKA Pharmaceutical Co., Ltd.