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Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma
Sponsor: Assistance Publique - Hôpitaux de Paris
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
Conditions
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
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