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NCT Number: NCT04791735

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chirurgie Digestive - CHU Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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.

    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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.

    Time frame: 90 days after inclusion

  7. 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

  8. Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.

    Time frame: 90 days after inclusion

  9. 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

  10. Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively

    Time frame: 90 days after inclusion

  11. 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

  12. Mean surgical margin widths (in millimeters).

    Time frame: inclusion

  13. Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.

    Time frame: inclusion

  14. 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).

  15. Overall and disease free survivals.

    Time frame: 60 month

    percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: LapCHC

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Mar 10, 2021
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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