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

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparoscopy
Laparotomy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring laparoscopy, laparotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chirurgie Digestive - CHU AmiensRecruiting
  • Chirurgie viscérale et digestive - CHU BesançonRecruiting
  • Chirurgie Hépatologie - Hôpital BeaujonRecruiting
  • Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-MondorRecruiting
  • Chirurgie Digestive et de l'Urgence - CHU GrenobleRecruiting
  • Chirurgie Digestive et Transplantations - Hôpital HuriezRecruiting
  • Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix RousseRecruiting
  • Chirurgie Digestive - Hôpital La Timone
  • Chirurgie Digestive - CHU MontpellierRecruiting
  • Chirurgie digestive - Institut Mutualiste MontsourisRecruiting
  • Cochin hospitalRecruiting
  • Chirurgie hépato-biliaire et greffe de foie - La PitiéRecruiting
  • Chirurgie viscérale et digestive - CHU RouenRecruiting
  • Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil
  • Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU ToursRecruiting
  • Centre hépatobiliaire de transplantation hépatique - Hopital Paul BrousseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Laparoscopic approach for liver resection of HCC

laparotomy

Arm Description

Outcomes

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.
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.
Number of postoperative complications (grade at least 3 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
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.
Occurrence of specific liver related complications (ascites, liver failure, biliary fistula, hemorrhage) within 90 days postoperatively or at any time during hospitalization.
Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.
Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.
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.
Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.
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
Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively
Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90
PQRS = Postoperative Suality Recovery Scane self-questionary Min = 20 and Max = 120
Mean surgical margin widths (in millimeters).
Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.
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).
Overall and disease free survivals.
percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up

Full Information

First Posted
January 7, 2021
Last Updated
January 3, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04791735
Brief Title
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma
Acronym
LapCHC
Official Title
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
laparoscopy, laparotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic approach for liver resection of HCC
Arm Type
Experimental
Arm Title
laparotomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Laparotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization
Time Frame
90 days after inclusion
Secondary Outcome Measure Information:
Title
Number of postoperative complications (grade at least 1 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
Time Frame
90 days after inclusion
Title
Number of postoperative complications (grade at least 3 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
Time Frame
90 days after inclusion
Title
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.
Time Frame
90 days after inclusion
Title
Occurrence of specific liver related complications (ascites, liver failure, biliary fistula, hemorrhage) within 90 days postoperatively or at any time during hospitalization.
Time Frame
90 days after inclusion
Title
Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.
Time Frame
90 days after inclusion
Title
Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.
Time Frame
90 days after inclusion
Title
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.
Time Frame
90 days after inclusion
Title
Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.
Time Frame
90 days after inclusion
Title
Postoperative pain evaluated with a visual analogic scale on postoperative D0, D1, D2, D3, D5, D7 and discharge.
Description
EVA is visual analogic scale 0 to 10, graduation of 1 0 is no pain ans 10 is maximum pain
Time Frame
day of surgery, 1, 2, 3, 5 and 7 days after surgery
Title
Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively
Time Frame
90 days after inclusion
Title
Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90
Description
PQRS = Postoperative Suality Recovery Scane self-questionary Min = 20 and Max = 120
Time Frame
1, 3, 5, 7, 30, 60, 90 days after inclusion
Title
Mean surgical margin widths (in millimeters).
Time Frame
inclusion
Title
Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.
Time Frame
inclusion
Title
Percentage of patients recurring within 2 years following liver resection.
Description
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).
Time Frame
inclusion
Title
Overall and disease free survivals.
Description
percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up
Time Frame
60 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chirurgie Digestive - CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
REGIMBEAU Jean Marc
Phone
03 22 08 88 90
Email
regimbeau.jean-marc@chu-amiens.fr
Facility Name
Chirurgie viscérale et digestive - CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TURCO Celia
Phone
0381668322
Email
cturco@chu-besancon.fr
Facility Name
Chirurgie Hépatologie - Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CAUCHY Francois
Phone
06 46 53 58 75
Email
francois.cauchy@aphp.fr
Facility Name
Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LAURENT Alexis
Phone
+33 (0) 1 49 81 24 08
Email
alexis.laurent@aphp.fr
Facility Name
Chirurgie Digestive et de l'Urgence - CHU Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIRICA Mircea
Phone
0476765428
Email
mchirica@chu-grenoble.fr
Facility Name
Chirurgie Digestive et Transplantations - Hôpital Huriez
City
Lille
ZIP/Postal Code
59021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BOLESLAWSKI Emmanuel
Phone
06 19 84 01 41
Email
emmanuel.boleslawski@gmail.com
Facility Name
Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOHKAM Kayvan
Phone
04 72 07 11 00
Email
kayvan.mohkam@chu-lyon.fr
Facility Name
Chirurgie Digestive - Hôpital La Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Chirurgie Digestive - CHU Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HERRERO Astrid
Phone
04 67 33 79 14
Email
a-herrero@chu-montpellier.fr
Facility Name
Chirurgie digestive - Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SOUBRANE Olivier
Phone
01 56 61 63 36
Email
olivier.soubrane@imm.fr
Facility Name
Cochin hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FUKS David
Phone
01 58 41 50 09
Email
david.fuks@aphp.fr
Facility Name
Chirurgie hépato-biliaire et greffe de foie - La Pitié
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SCATTON Olivier
Phone
01 84 82 74 27
Email
olivier.scatton@aphp.fr
Facility Name
Chirurgie viscérale et digestive - CHU Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SCWARZ Lilian
Phone
02 32 88 84 18
Email
lilian.sclilian.scwarz@chu-rouen.frwarz@chu-rouen.fr
Facility Name
Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BUCUR Petru
Phone
06 29 42 13 64
Email
bucur.petru@chu-tours.fr
Facility Name
Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHERQUI Daniel
Phone
01 45 59 30 36
Email
daniel.cherqui@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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