Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopy | Procedure | — | UNRESOLVED |
| Laparotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic approach for liver resection of HCC
- interventionNames
- Procedure: Laparoscopy
- type
- EXPERIMENTAL
- label
- laparotomy
- interventionNames
- Procedure: Laparotomy
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 90 days after inclusion
- description
- Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available