Clinical trial NCT04791735: Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma
Official title: Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: laparoscopy
laparotomy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 90 days after inclusion
Secondary outcomes:
measure: Number of postoperative complications (grade at least 1 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
timeFrame: 90 days after inclusion
measure: Number of postoperative complications (grade at least 3 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
timeFrame: 90 days after inclusion
measure: 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.
timeFrame: 90 days after inclusion
measure: Occurrence of specific liver related complications (ascites, liver failure, biliary fistula, hemorrhage) within 90 days postoperatively or at any time during hospitalization.
timeFrame: 90 days after inclusion
measure: Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.
timeFrame: 90 days after inclusion
measure: Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.
timeFrame: 90 days after inclusion
measure: 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.
timeFrame: 90 days after inclusion
measure: Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.
timeFrame: 90 days after inclusion
measure: Postoperative pain evaluated with a visual analogic scale on postoperative D0, D1, D2, D3, D5, D7 and discharge.
timeFrame: day of surgery, 1, 2, 3, 5 and 7 days after surgery
measure: Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively
timeFrame: 90 days after inclusion
measure: Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90
timeFrame: 1, 3, 5, 7, 30, 60, 90 days after inclusion
measure: Mean surgical margin widths (in millimeters).
timeFrame: inclusion
measure: Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.
timeFrame: inclusion
measure: Percentage of patients recurring within 2 years following liver resection.
timeFrame: inclusion
measure: Overall and disease free survivals.
timeFrame: 60 month
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chirurgie Digestive - CHU Amiens
city: Besançon
country: France
facility: Chirurgie viscérale et digestive - CHU Besançon
city: Clichy
country: France
facility: Chirurgie Hépatologie - Hôpital Beaujon
city: Créteil
country: France
facility: Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor
city: Grenoble
country: France
facility: Chirurgie Digestive et de l'Urgence - CHU Grenoble
city: Lille
country: France
facility: Chirurgie Digestive et Transplantations - Hôpital Huriez
city: Lyon
country: France
facility: Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Chirurgie Digestive - Hôpital La Timone
city: Montpellier
country: France
facility: Chirurgie Digestive - CHU Montpellier
city: Paris
country: France
facility: Chirurgie digestive - Institut Mutualiste Montsouris
city: Paris
country: France
facility: Cochin hospital
city: Paris
country: France
facility: Chirurgie hépato-biliaire et greffe de foie - La Pitié
city: Rennes
country: France
facility: CHU Rennes - Pontchaillou
city: Rouen
country: France
facility: Chirurgie viscérale et digestive - CHU Rouen
city: Toulouse
country: France
facility: Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil
city: Tours
country: France
facility: Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours
city: Villejuif
country: France
facility: Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse
Study officials:
References: