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

NCT04791735 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-05-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2025-04-30
Completion
2027-05-07

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791735 on ClinicalTrials.gov