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

NCT04791735 | Active Not Recruiting DMC

• 1 other identifier: APHP180681
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 17

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

Keywords

laparoscopy; laparotomy

Outcome Measures

Primary Outcomes (1)

• 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

  90 days after inclusion

Secondary Outcomes (15)

• Number of postoperative complications (grade at least 1 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.

  90 days after inclusion

• Number of postoperative complications (grade at least 3 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.

  90 days after inclusion

• All-cause mortality (grade 5 according to the Dindo-Clavien classification or a CCI of 100) within 90 days postoperatively or at any time during hospitalization.

  90 days after inclusion

• Occurrence of specific liver related complications (ascites, liver failure, biliary fistula, hemorrhage) within 90 days postoperatively or at any time during hospitalization.

  90 days after inclusion

• Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.

  90 days after inclusion

Study Arms (2)

Laparoscopic approach for liver resection of HCC

EXPERIMENTAL

Procedure: Laparoscopy

laparotomy

EXPERIMENTAL

Procedure: Laparotomy

Interventions

Laparoscopy 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

Laparoscopic approach for liver resection of HCC

Laparotomy 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.

laparotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged ≥ 18 years
• Presenting with solitary or multifocal resectable HCC
• Qualifying for both pure laparoscopic and open approaches

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (17)

Chirurgie Digestive - CHU Amiens

Amiens, France, 80054, France

Location

Chirurgie viscérale et digestive - CHU Besançon

Besançon, France, 25000, France

Location

Chirurgie Hépatologie - Hôpital Beaujon

Clichy, France, 92110, France

Location

Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor

Créteil, France, 94010, France

Location

Chirurgie Digestive et de l'Urgence - CHU Grenoble

Grenoble, France, 38700, France

Location

Chirurgie Digestive et Transplantations - Hôpital Huriez

Lille, France, 59021, France

Location

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

Lyon, France, 69317, France

Location

Chirurgie Digestive - CHU Montpellier

Montpellier, France, 34090, France

Location

Chirurgie digestive - Institut Mutualiste Montsouris

Paris, France, 75014, France

Location

Cochin hospital

Paris, France, 75014, France

Location

Chirurgie hépato-biliaire et greffe de foie - La Pitié

Paris, France, 75651, France

Location

Chirurgie viscérale et digestive - CHU Rouen

Rouen, France, 76000, France

Location

Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil

Toulouse, France, 31059, France

Location

Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours

Tours, France, 37000, France

Location

Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse

Villejuif, France, 94800, France

Location

Chirurgie Digestive - Hôpital La Timone

Marseille, 13005, France

Location

CHU Rennes - Pontchaillou

Rennes, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Laparoscopy; Laparotomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the intervention group is Laparoscopic approach for liver resection of HCC The standard arm is the open approach for liver resection of HCC. Both this standard arm and the laparoscopic arm are in the realm of usual care.

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: March 10, 2021
• Study Start: May 21, 2021
• Primary Completion: April 30, 2025
• Study Completion (Estimated): May 7, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)