Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma

N/AActive Not RecruitingNCT04791735

Assistance Publique - Hôpitaux de Paris252 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

252

Conditions

Hepatocellular Carcinoma

Interventions

LaparoscopyPROCEDURE

* Installations of the patient: the position of the patient will depend on both extent of resection and location of the lesion. * Absence of laparotomy with the exception of the extraction of the resected specimen and absence of costal retractors. * Use of laparoscopic specific devices: * Use of multiple (3-7) ports depending on the operator's preference and technical difficulty (mainly 5-6 ports for major liver resection). * Use of a laparoscopic camera system with 0° or 30° * Use of a dedicated laparoscopic ultrasound probe. * Use of specific laparoscopic devices for coagulation, parenchymal transection and sealing. * Placement of the resected specimen in a plastic bag and extraction without fragmentation, depending on the surgeon's preferenceand the diameter of the resected specimen

LaparotomyPROCEDURE

* Installation of the patient: patients will be placed in supine position, the surgeon operating on the right side of the patient and the assistant standing on the left side. * Incision: the type of incision will depend on both the nature of the resection and the operator's preference. Various incisions such as bi subcostal incision, J-shaped incision, right subcostal incision and midline incision can be used. * Use of open surgical instruments and devices for coagulation and parenchymal transection. These may include the crush-clamp technique or ultrasonic dissection for parenchymal transection, bipolar coagulation, clips, sutures or open vascular stapler for hemostasis and biliostasis. * Methylene blue injection through the cystic drain to rule out biliary leakage will be performed depending on the surgeon's preference.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Chirurgie Digestive - CHU Amiens

Amiens, France, France

Chirurgie viscérale et digestive - CHU Besançon

Besançon, France, France

Outcomes

Primary Outcomes

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