Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma (LapCHC)

Assistance Publique - Hôpitaux de Paris

Status

Active, not recruiting

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Laparotomy

Procedure: Laparoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04791735

APHP180681

Details and patient eligibility

About

Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.

Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization

Enrollment

252 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patient aged ≥ 18 years
Presenting with solitary or multifocal resectable HCC
Qualifying for both pure laparoscopic and open approaches

Exclusion criteria

Physical or psychological status contraindicating the participation to the study
Contraindication to surgery
Contraindication to pneumoperitoneum
ASA (American Society of Anesthesiologists) score IV-V
Life expectancy < 2 months
Suspicion of mixed type tumor (Hepatocholangiocarcinoma) and fibrolamellar HCC
Child-Pugh score > B7
Extra-hepatic involvement
Liver resection requiring an associated vascular or biliary reconstruction
Pregnancy and breast-feeding
Tutorship, trusteeship
Concurrent participation in other experimental trials concerning the same objective within 90 days following intervention
No Affiliation to the French social security
No Ability to give their consent and not written informed consent