Administration of Rifaximin to Improve Liver Regeneration and Outcome Following Major Liver Resection (ARROW)
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|ClinicalTrials.gov Identifier: NCT02555293|
Recruitment Status : Active, not recruiting
First Posted : September 21, 2015
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Liver Disease Major Liver Resection||Drug: XIFAXAN® (Rifaximin)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Administration of Rifaximin to Improve Liver Regeneration and Outcome Following Major Liver Resection|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: film-coated Rifaximin (550 mg)
(550 mg) tablet twice daily for at least 14 days but up to 28 days dependent on the need for a PVE and the period between PVE (portal vein embolization) or randomization and surgery. Preoperative Rifaximin treatment in case of a PVE will start the day after PVE and will last for 14-21 days. In case patients are not pre-treated with a PVE they will receive Rifaximin for 7-10 days prior to surgery. Regardless of PVE, patients will receive additional Rifaximin treatment the first 7 days postoperatively.
Drug: XIFAXAN® (Rifaximin)
Other Name: NDA 22-554
No Intervention: standard therapy
Patients directed to the control group will not receive Rifaximin.
- Effect of Rifaximin on postoperative liver function [ Time Frame: Postoperative day 7 in relation to postoperative day 4 ]
LiMAx liver function percentage increase on postoperative day 7 in relation to LiMAx value on postoperative day 4 compared to a control group without Rifaximin treatment.
LiMAx will be made after at least 14 days but up to 28 days of treatment (control group analogue) dependent on the need for a PVE and the period between PVE or randomization and surgery
- postoperative morbidity/Complications [ Time Frame: minimum 14 days after liver resection ]Complications will be scored using the Clavien-Dindo scoring system and a liver-specific-composite-endpoint for the duration of hospital stay, an expected average of minimum 14 days
- Liver volume percentage increase [ Time Frame: 14 up to 21 days before liver resection at baseline and 7 days after the operation ]
pre- and postoperative comperative measurements mainly based on suitable, preoperatively and routinely done MRI/CT-images. On postoperative day 7 as tudy related MRI will be done if no CT/MRI images available routinely done 1 day before or one day after visit 5
- liver function percentage increase [ Time Frame: 14 up to 21 days before liver resection at baseline (all), on preoperative day 1 (PVE group only) and on postoperative day 4 and day 7 (all) ]
LiMAx liver function testing will be performed before surgery and on postoperative days 4 and 7 to evaluate functional recovery after liver resection.
- Time to functional recovery [ Time Frame: minimum 14 days starting on operation day ]
The evaluation of time to functional recovery will start on POD 0 and will be scored daily until discharge from the hospital with the following criteria
- Adequate pain control on oral analgesics only
- Eating and drinking properly without the need of IV fluids
- Independently mobile or mobile at preoperative level
- Standard laboratory tests and liver function returning to normal level When all of these criteria are met, we consider a patient functional recovered.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555293
|RWTH Aachen University|
|Aachen, Germany, 52074|