Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT02555293
Eligibility Criteria:
Inclusion Criteria:
1. Patients undergoing a liver resection of at least 4 segments
2. Age \> 18 years \< 80 years
3. BMI 18-40
4. Patients with ASA (American Society of Anesthesiologists) I-III
5. Written informed consent prior to study participation
Exclusion Criteria:
1. Patients with ASA IV-V
2. Contraindication for MRI (see 5.4.3)
3. Underlying chronic liver disease such as severe fibrosis or liver cirrhosis
4. Need for procedures additive to partial liver resection
5. Participation in other liver related trials
6. BMI \> 40
7. Previous liver transplantation or porto-systemic shunt
8. Concomitant acute infectious diseases
9. Renal insufficiency
10. Hypersensitivity to Rifaximin
11. Concomitant HIPEC (hypertherme intraperitoneale chemoperfusion) treatment
12. ALPPS (associating liver partition and portal vein ligation for staged hepatectomy)
13. Pregnant females as determined by positive \[serum or urine\] hCG (human chorionic gonadotropin) test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
14. Lactating females
15. 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.
16. The subject received an investigational drug within 30 days prior to inclusion into this study
17. 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
18. The subject is unwilling or unable to follow the procedures outlined in the protocol
19. The subject is mentally or legally incapacitated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02555293
Study Brief:
Protocol Section:
NCT02555293