Administration of Rifaximin to improve liver regeneration and function after liver resectio

Phase 1

• Conditions: Patients undergoing major liver resection will be included into the study; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004644-28-DE
• Lead Sponsor: RWTH Aachen University, represented by the Rector, himself, represented by the Dean of the Medical Faculty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-18
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1.Patients undergoing a liver resection of at least 3 segments
2.Age = 18 years = 80 years
3.BMI 18 – 40
4.Patients with ASA I-III
5.Written informed consent prior to study participation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Patients assessed ASA IV-V
2.Contraindication for MRT or LiMAx
3.Need for extrahepatic procedures additive to partial liver resection
4.Participation in other liver related trials
5.BMI <18, > 40
6.Previous liver transplantation or porto-systemic shunt
7.Concomitant acute infectious diseases
8.Dialysis dependent renal failure
9.Hypersensitivity to Rifaximin
10.Concomitant Heated Intraperitoneal Chemotherapy (HIPEC) treatment
11.ALPPS (associating liver partition and portal vein ligation for staged hepatectomy)
12.Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
13.Lactating females
14.The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
15.The subject received an investigational drug within 30 days prior to inclusion into this study
16.The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
17.The subject is unwilling or unable to follow the procedures outlined in the protocol
18.The subject is mentally or legally incapacitated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to examine the effect of Rifaximin on postoperative liver function in patients with malignant or benign liver disease requiring major liver resection;Secondary Objective: to examine postoperative morbidity;Primary end point(s): Liver function will be assessed by LiMAx analysis on postoperative day 4 and day 7;Timepoint(s) of evaluation of this end point: after last patient out a batch analysis will be performed

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Assessment of postoperative morbidity by using the Clavien-Dindo-Score;Timepoint(s) of evaluation of this end point: after last patient out a batch analysis will be performed