malignant tumor malignant tumor with distal biliary obstruction
Conditions
Interventions
Oral rifaximin administration after placement of self-expandable metallic stent for distal malignant biliary obstruction.
rifaximin
Sponsors
Kai Yugo
Ohkawa Kazuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of cholangitis | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactYugo Kai
Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute
Outcome results
None listed