NCT04791735Active, not recruiting
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 28 May 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- First submitted
- 7 Jan 2021
- Start date
- 21 May 2021
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04791735
What you commit to
- Study type: Interventional
- Planned participants: 252
- From 21 May 2021 to the primary completion date, 30 Apr 2025
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to surgery
- Liver resection requiring an associated vascular or biliary reconstruction
- Concurrent participation in other experimental trials concerning the same objective within 90 days following intervention
Other
- Physical or psychological status contraindicating the participation to the study
- 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
- Pregnancy and breast-feeding
- Tutorship, trusteeship
- No Affiliation to the French social security
- No Ability to give their consent and not written informed consent
Who the study is looking for
- Male or female patient aged ≥ 18 years
- Presenting with solitary or multifocal resectable HCC
- Qualifying for both pure laparoscopic and open approaches
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chirurgie Digestive - CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Chirurgie viscérale et digestive - CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Chirurgie Hépatologie - Hôpital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Unknown status |
| Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Chirurgie Digestive et de l'Urgence - CHU Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Chirurgie Digestive et Transplantations - Hôpital Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Chirurgie Digestive - Hôpital La Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Chirurgie Digestive - CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Cochin Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Chirurgie hépato-biliaire et greffe de foie - La Pitié Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Chirurgie digestive - Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Chu Rennes Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Chirurgie viscérale et digestive - CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.