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ACTIVE NOT RECRUITING
NCT04791735
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Official title: Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2021-05-21

Completion Date

2027-05-07

Last Updated

2025-05-28

Healthy Volunteers

No

Interventions

PROCEDURE

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

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.

Locations (17)

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