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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT06638502
Eligibility Criteria:
Inclusion Criteria:
1. Stable male and female patients between 18 and 75 years within 1-3 days after extended resection of the right or left liver lobe due to metastases of a colon carcinoma, but otherwise normal liver parenchyma proven by histopathology assessment of a liver biopsy within 3 months before surgery and liver functional parameters.
2. For the pilot phase less extended resections (remnant liver volume \>69%) are required)
3. Percentage of Remnant Liver Volume (RLV) 28%-50% (randomized part of the study)
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Exclusion Criteria:
1. Liver Cirrhosis
2. Preoperative presence of clinical ascites
3. Any other liver cancer
4. BMI \>35 kg/m2
5. ASA Score\>4
6. CC Score \>0: all patients with pre-operatively or intra-operatively diagnosed peritoneal carcinosis or other pre-op or intra-op findings which would deem the patient to be unresectable, are excluded.
7. Incomplete liver metastasis resection -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06638502
Study Brief:
Protocol Section:
NCT06638502