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

Last updated: November 28, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Abdominal Cancer

Liver Disorders

Digestive System Neoplasms

Treatment

Laparoscopy

Laparotomy

Clinical Study ID

NCT04791735
APHP180681
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

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

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 objectivewithin 90 days following intervention
  • No Affiliation to the French social security
  • No Ability to give their consent and not written informed consent

Study Design

Total Participants: 252
Treatment Group(s): 2
Primary Treatment: Laparoscopy
Phase:
Study Start date:
May 21, 2021
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Chirurgie Digestive - CHU Amiens

    Amiens, 80054
    France

    Active - Recruiting

  • Chirurgie viscérale et digestive - CHU Besançon

    Besançon, 25000
    France

    Active - Recruiting

  • Chirurgie viscérale et digestive - CHU Caean

    Caen, 14000
    France

    Site Not Available

  • Chirurgie Hépatologie - Hôpital Beaujon

    Clichy, 92110
    France

    Active - Recruiting

  • Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor

    Créteil, 94010
    France

    Active - Recruiting

  • Chirurgie Digestive et de l'Urgence - CHU Grenoble

    Grenoble, 38700
    France

    Active - Recruiting

  • Chirurgie Digestive et Transplantations - Hôpital Huriez

    Lille, 59021
    France

    Active - Recruiting

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

    Lyon, 69317
    France

    Active - Recruiting

  • Chirurgie Digestive - Hôpital La Timone

    Marseille, 13005
    France

    Site Not Available

  • Chirurgie Digestive - CHU Montpellier

    Montpellier, 34090
    France

    Active - Recruiting

  • Chirurgie digestive - Institut Mutualiste Montsouris

    Paris, 75014
    France

    Active - Recruiting

  • Chirurgie hépato-biliaire et greffe de foie - La Pitié

    Paris, 75651
    France

    Active - Recruiting

  • Cochin hospital

    Paris, 75014
    France

    Active - Recruiting

  • Chirurgie viscérale et digestive - CHU Rouen

    Rouen, 76000
    France

    Active - Recruiting

  • Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil

    Toulouse, 31059
    France

    Site Not Available

  • Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours

    Tours, 37000
    France

    Active - Recruiting

  • Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse

    Villejuif, 94800
    France

    Active - Recruiting

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