Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Procedure: LaparoscopyProcedure: Laparotomy
- Registration Number
- NCT04791735
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 252
- Male or female patient aged ≥ 18 years
- Presenting with solitary or multifocal resectable HCC
- Qualifying for both pure laparoscopic and open approaches
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic approach for liver resection of HCC Laparoscopy - laparotomy Laparotomy -
- Primary Outcome Measures
Name Time Method 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. 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 Outcome Measures
Name Time Method Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization. 90 days after inclusion Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively 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 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 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 Postoperative pain evaluated with a visual analogic scale on postoperative D0, D1, D2, D3, D5, D7 and discharge. 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
Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90 1, 3, 5, 7, 30, 60, 90 days after inclusion PQRS = Postoperative Suality Recovery Scane self-questionary Min = 20 and Max = 120
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. 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).
Overall and disease free survivals. 60 month percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up
Trial Locations
- Locations (16)
Chirurgie viscérale et digestive - CHU Besançon
🇫🇷Besançon, France
Chirurgie Digestive et Transplantations - Hôpital Huriez
🇫🇷Lille, France
Chirurgie Hépatologie - Hôpital Beaujon
🇫🇷Clichy, France
Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse
🇫🇷Villejuif, France
Chirurgie Digestive et de l'Urgence - CHU Grenoble
🇫🇷Grenoble, France
Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse
🇫🇷Lyon, France
Chirurgie Digestive - Hôpital La Timone
🇫🇷Marseille, France
Chirurgie Digestive - CHU Montpellier
🇫🇷Montpellier, France
Chirurgie digestive - Institut Mutualiste Montsouris
🇫🇷Paris, France
Cochin hospital
🇫🇷Paris, France
Chirurgie viscérale et digestive - CHU Rouen
🇫🇷Rouen, France
Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil
🇫🇷Toulouse, France
Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours
🇫🇷Tours, France
Chirurgie Digestive - CHU Amiens
🇫🇷Amiens, France
Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor
🇫🇷Créteil, France
Chirurgie hépato-biliaire et greffe de foie - La Pitié
🇫🇷Paris, France