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:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT03208192
Eligibility Criteria:
Inclusion Criteria:
* Patients with benign lesions (hemangioma, focal nodular hyperplasia \[FNH\], hepatocellular adenoma, biliary cystadenoma, hydatid echinococcosis \[only with total pericystectomy\]) and malignant tumors (colorectal cancer metastases in the liver \[CRLM\], hepatocellular carcinoma \[HCC\], intrahepatic cholangiocellular carcinoma, gallbladder cancer T1b-3NxMo without invasion into bile ducts and adjacent organs), which involves laparoscopic segmental or major resection of the liver.
* Gender: both, male and female
* Minimum age 18 years
* Maximum age: 80 years
* ASA physical status I-IV
* BMI up to 40 kg/m2
* No simultaneous extrahepatic intra-abdominal procedures (bile duct resection, colon resection, partial duodenum resection)
* Total bilirubin up to 100mmol/l if jaundice presents in non-cirrhotic patients
* If cirrhosis is present, class A and B according to CTP score
Exclusion Criteria:
* • Difficulty index \> 12 points (see below)
* Tumor invasion of IVC or portal trunk (necessity of vascular reconstruction)
* Repeated liver resection before laparoscopic resection (the single resection before is not a contraindication)
* Simultaneous extra-hepatic intra-abdominal procedures (bile duct resection, colon resection etc.)
* Age under 18 years
* Age above 80 years
* ASA physical status \>IV
* BMI \> 40 kg/m2
* Total bilirubin \>100mmol/l if jaundice presents in non-cirrhotic patients
* If cirrhosis is present, class C according to CTP score
* Persons who are incapable of giving consent
* Pregnant or breast-feeding women
* Patients enlisted in other studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03208192
Study Brief:
Protocol Section:
NCT03208192