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

Phase 2

Recruiting

• Conditions: malignant tumor; malignant tumor with distal biliary obstruction

• Registration Number: JPRN-jRCTs051210173
• Lead Sponsor: Ikezawa Kenji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified