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

Study Overview
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Brief Summary
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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

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Laparoscopy
* Procedure: Laparotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic approach for liver resection of HCC<br> | Procedure: Laparoscopy<br>* 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<br>|
| Experimental: laparotomy<br> | Procedure: Laparotomy<br>* 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.<br>|

What is the study measuring?
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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. | 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. |  | 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 | 
| Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization. |  | 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. |  | 90 days after inclusion | 
| Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization. |  | 90 days after inclusion | 
| Postoperative pain evaluated with a visual analogic scale on postoperative D0, D1, D2, D3, D5, D7 and discharge. | 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 |  | 90 days after inclusion | 
| Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90 | 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). |  | inclusion | 
| Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report. |  | inclusion | 
| Percentage of patients recurring within 2 years following liver resection. | 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. | percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up | 60 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, laparotomy