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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04791735

Collaborator

(none)

252

Enrollment

Locations

Arms

59.3

Anticipated Duration (Months)

15.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: Laparoscopy Procedure: Laparotomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 21, 2021

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic approach for liver resection of HCC	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
Experimental: laparotomy	Procedure: 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.

Arm

Intervention/Treatment

Experimental: Laparoscopic approach for liver resection of HCC

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

Experimental: laparotomy

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

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. [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
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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Chirurgie Digestive - CHU Amiens	Amiens	France	80054
2	Chirurgie viscérale et digestive - CHU Besançon	Besançon	France	25000
3	Chirurgie Hépatologie - Hôpital Beaujon	Clichy	France	92110
4	Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor	Créteil	France	94010
5	Chirurgie Digestive et de l'Urgence - CHU Grenoble	Grenoble	France	38700
6	Chirurgie Digestive et Transplantations - Hôpital Huriez	Lille	France	59021
7	Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse	Lyon	France	69317
8	Chirurgie Digestive - Hôpital La Timone	Marseille	France	13005
9	Chirurgie Digestive - CHU Montpellier	Montpellier	France	34090
10	Chirurgie digestive - Institut Mutualiste Montsouris	Paris	France	75014
11	Cochin hospital	Paris	France	75014
12	Chirurgie hépato-biliaire et greffe de foie - La Pitié	Paris	France	75651
13	Chirurgie viscérale et digestive - CHU Rouen	Rouen	France	76000
14	Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil	Toulouse	France	31059
15	Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours	Tours	France	37000
16	Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse	Villejuif	France	94800

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04791735

Other Study ID Numbers:

APHP180681

First Posted:

Mar 10, 2021

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Assistance Publique - Hôpitaux de Paris

laparoscopy

laparotomy

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jun 22, 2022