Clinical trial · Interventional
Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases
Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study
NCT04163887CI-TRIAL-00056661METALAPunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of the procedure or regardless of the date during the hospital stay.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hepatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- laparoscopic liver resection
- description
- Laparoscopy allows some surgical procedures to be performed through small incisions that enable the operator to access the abdominal cavity, often at the pubic area, and surgical instruments are introduced through these small incisions. This technique avoids large abdominal incisions and significantly reduces the duration of hospitalization.
- interventionNames
- Procedure: hepatectomy
- type
- OTHER
- label
- open liver resection
- description
- standard of care
- interventionNames
- Procedure: hepatectomy
Primary outcomes (1)
- measure
- Rate of overall complications using the comprehensive complication Index (CCI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Presenting with colorectal liver metastases requiring liver resection ± concomitant radiofrequency ablation. * Qualifying for both a laparoscopic approach and an open approach. * Informed written consent. * Affiliated to health insurance regimen. Exclusion Criteria: * Hybrid liver resection (including both laparoscopic and open resection). * Liver resection requiring an associated vascular or biliary reconstruction. * Contraindication to surgery. * Contraindication to laparoscopy (pneumoperitoneum). * ASA (American Society of Anesthesiologists) score IV or V or life expectancy \< 3 months. * Poor comprehension of French language or cognitive impairment * Pregnancy or breastfeeding. * Patient under guardianship or unable to give consent * People particularly protected by French law.
References
Publications (60)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5. PMID 25559415
- BACKGROUNDManfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9. doi: 10.1097/01.sla.0000217629.94941.cf. PMID 16858188
- BACKGROUNDPower DG, Kemeny NE. Role of adjuvant therapy after resection of colorectal cancer liver metastases. J Clin Oncol. 2010 May 1;28(13):2300-9. doi: 10.1200/JCO.2009.26.9340. Epub 2010 Apr 5. PMID 20368552
- BACKGROUNDKomatsu S, Scatton O, Goumard C, Sepulveda A, Brustia R, Perdigao F, Soubrane O. Development Process and Technical Aspects of Laparoscopic Hepatectomy: Learning Curve Based on 15 Years of Experience. J Am Coll Surg. 2017 May;224(5):841-850. doi: 10.1016/j.jamcollsurg.2016.12.037. Epub 2017 Jan 20. PMID 28111192
- BACKGROUNDFuks D, Cauchy F, Fteriche S, Nomi T, Schwarz L, Dokmak S, Scatton O, Fusco G, Belghiti J, Gayet B, Soubrane O. Laparoscopy Decreases Pulmonary Complications in Patients Undergoing Major Liver Resection: A Propensity Score Analysis. Ann Surg. 2016 Feb;263(2):353-61. doi: 10.1097/SLA.0000000000001140. PMID 25607769
- BACKGROUNDNomi T, Fuks D, Ogiso S, Nakajima Y, Louvet C, Gayet B. Second and Third Laparoscopic Liver Resection for Patients With Recurrent Colorectal Liver Metastases. Ann Surg. 2016 May;263(5):e68-72. doi: 10.1097/SLA.0000000000001528. No abstract available. PMID 26641255
- BACKGROUNDCiria R, Cherqui D, Geller DA, Briceno J, Wakabayashi G. Comparative Short-term Benefits of Laparoscopic Liver Resection: 9000 Cases and Climbing. Ann Surg. 2016 Apr;263(4):761-77. doi: 10.1097/SLA.0000000000001413.