Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma (LapCHC)

November 28, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
      • Besançon, France, 25000
        • Recruiting
        • Chirurgie viscérale et digestive - CHU Besançon
        • Contact:
      • Clichy, France, 92110
        • Recruiting
        • Chirurgie Hépatologie - Hôpital Beaujon
        • Contact:
      • Créteil, France, 94010
        • Recruiting
        • Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor
        • Contact:
      • Grenoble, France, 38700
        • Recruiting
        • Chirurgie Digestive et de l'Urgence - CHU Grenoble
        • Contact:
      • Lille, France, 59021
        • Recruiting
        • Chirurgie Digestive et Transplantations - Hôpital Huriez
        • Contact:
      • Lyon, France, 69317
        • Recruiting
        • Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse
        • Contact:
      • Marseille, France, 13005
        • Active, not recruiting
        • Chirurgie Digestive - Hôpital La Timone
      • Montpellier, France, 34090
      • Paris, France, 75014
        • Recruiting
        • Cochin Hospital
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Chirurgie digestive - Institut Mutualiste Montsouris
        • Contact:
      • Paris, France, 75651
        • Recruiting
        • Chirurgie hépato-biliaire et greffe de foie - La Pitié
        • Contact:
      • Rouen, France, 76000
      • Toulouse, France, 31059
        • Active, not recruiting
        • Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil
      • Tours, France, 37000
        • Recruiting
        • Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours
        • Contact:
      • Villejuif, France, 94800
        • Recruiting
        • Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic approach for liver resection of HCC
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
Experimental: laparotomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 90 days after inclusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of postoperative complications (grade at least 1 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
Time Frame: 90 days after inclusion
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.
Time Frame: 90 days after inclusion
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.
Time Frame: 90 days after inclusion
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.
Time Frame: 90 days after inclusion
90 days after inclusion
Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.
Time Frame: 90 days after inclusion
90 days after inclusion
Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.
Time Frame: 90 days after inclusion
90 days after inclusion
Occurrence of postoperative pulmonary complications (pleural effusion, respiratory insufficiency, acute respiratory distress syndrome, pulmonary embolism) within 90 days postoperatively or at any time during hospitalization.
Time Frame: 90 days after inclusion
90 days after inclusion
Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.
Time Frame: 90 days after inclusion
90 days after inclusion
Postoperative pain evaluated with a visual analogic scale on postoperative D0, D1, D2, D3, D5, D7 and discharge.
Time Frame: day of surgery, 1, 2, 3, 5 and 7 days after surgery
EVA is visual analogic scale 0 to 10, graduation of 1 0 is no pain ans 10 is maximum pain
day of surgery, 1, 2, 3, 5 and 7 days after surgery
Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively
Time Frame: 90 days after inclusion
90 days after inclusion
Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90
Time Frame: 1, 3, 5, 7, 30, 60, 90 days after inclusion
PQRS = Postoperative Suality Recovery Scane self-questionary Min = 20 and Max = 120
1, 3, 5, 7, 30, 60, 90 days after inclusion
Mean surgical margin widths (in millimeters).
Time Frame: inclusion
inclusion
Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.
Time Frame: inclusion
inclusion
Percentage of patients recurring within 2 years following liver resection.
Time Frame: inclusion
This cut-off value is widely accepted for differentiating recurrence of the resected lesion (< 2 years postoperatively) from de novo lesion occurring on a background diseased liver parenchyma (> 2 years).
inclusion
Overall and disease free survivals.
Time Frame: 60 month
percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up
60 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180681

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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