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

NCT ID: NCT04791735

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2027-05-07

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic approach for liver resection of HCC

Group Type: EXPERIMENTAL

Laparoscopy

Intervention Type: PROCEDURE

• 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

laparotomy

Group Type: EXPERIMENTAL

Laparotomy

Intervention Type: PROCEDURE

• 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.

Interventions

Laparoscopy

• 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

Intervention Type: PROCEDURE

Laparotomy

• 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chirurgie Digestive - CHU Amiens

Amiens, France, France

Chirurgie viscérale et digestive - CHU Besançon

Besançon, France, France

Chirurgie Hépatologie - Hôpital Beaujon

Clichy, France, France

Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor

Créteil, France, France

Chirurgie Digestive et de l'Urgence - CHU Grenoble

Grenoble, France, France

Chirurgie Digestive et Transplantations - Hôpital Huriez

Lille, France, France

Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse

Lyon, France, France

Chirurgie Digestive - CHU Montpellier

Montpellier, France, France

Chirurgie digestive - Institut Mutualiste Montsouris

Paris, France, France

Cochin hospital

Paris, France, France

Chirurgie hépato-biliaire et greffe de foie - La Pitié

Paris, France, France

Chirurgie viscérale et digestive - CHU Rouen

Rouen, France, France

Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil

Toulouse, France, France

Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours

Tours, France, France

Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse

Villejuif, France, France

Chirurgie Digestive - Hôpital La Timone

Marseille, , France

CHU Rennes - Pontchaillou

Rennes, , France

Countries

France

Other Identifiers

APHP180681

Identifier Type: -

Identifier Source: org_study_id