Status:
ACTIVE_NOT_RECRUITING
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 demonstr...
Eligibility Criteria
Inclusion
- Male or female patient aged ≥ 18 years
- Presenting with solitary or multifocal resectable HCC
- Qualifying for both pure laparoscopic and open approaches
Exclusion
- 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
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 7 2027
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT04791735
Start Date
May 21 2021
End Date
May 7 2027
Last Update
May 28 2025
Active Locations (17)
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1
Chirurgie Digestive - CHU Amiens
Amiens, France, France, 80054
2
Chirurgie viscérale et digestive - CHU Besançon
Besançon, France, France, 25000
3
Chirurgie Hépatologie - Hôpital Beaujon
Clichy, France, France, 92110
4
Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor
Créteil, France, France, 94010