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

Hepatocellular Carcinoma Clinical Trial

— LapCHC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791735
• Other study ID #: APHP180681
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: May 2026

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: May 2026
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Chirurgie Digestive - CHU Amiens	Amiens
France	Chirurgie viscérale et digestive - CHU Besançon	Besançon
France	Chirurgie Hépatologie - Hôpital Beaujon	Clichy
France	Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor	Créteil
France	Chirurgie Digestive et de l'Urgence - CHU Grenoble	Grenoble
France	Chirurgie Digestive et Transplantations - Hôpital Huriez	Lille
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	Chirurgie hépato-biliaire et greffe de foie - La Pitié	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	Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.		90 days after inclusion
Secondary	Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.		90 days after inclusion
Secondary	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
Secondary	Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.		90 days after inclusion
Secondary	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
Secondary	Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively		90 days after inclusion
Secondary	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
Secondary	Mean surgical margin widths (in millimeters).		inclusion
Secondary	Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.		inclusion
Secondary	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
Secondary	Overall and disease free survivals.	percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up	60 month