Laparoscopic surgery for liver metastases from colon cancer
Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study
NA · Institut Mutualiste Montsouris · NCT04163887
This study is testing if laparoscopic surgery for liver tumors from colon cancer leads to fewer complications and better recovery compared to traditional open surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Mutualiste Montsouris (other) |
| Locations | 21 sites (Amiens and 20 other locations) |
| Trial ID | NCT04163887 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the laparoscopic approach to the traditional open approach for liver resection in patients with colorectal liver metastases. It will assess the reduction of postoperative complications, including mortality, using the Comprehensive Complication Index (CCI) within 90 days post-surgery. Patients will be randomly assigned to either the laparoscopic or open surgery groups, and their recovery will be monitored over a three-year period. The goal is to demonstrate that laparoscopic surgery can lead to fewer complications and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with colorectal liver metastases who qualify for both laparoscopic and open surgical approaches.
Not a fit: Patients with contraindications to surgery or laparoscopy, or those with severe comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery times for patients undergoing liver resection.
How similar studies have performed: Previous studies have indicated that laparoscopic approaches can reduce complications in various surgical contexts, suggesting potential success for this method in liver resections.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Amiens and 20 other locations
- CHU Amiens Picardie — Amiens, France (NOT_YET_RECRUITING)
- Hôpital Côte de Nacre - Chu Caen — Caen, France (NOT_YET_RECRUITING)
- CHU Estaing — Clermont-Ferrand, France (NOT_YET_RECRUITING)
- Hôpital Beaujon — Clichy, France (RECRUITING)
- CHU Henri Mondor — Créteil, France (RECRUITING)
- CHU de Grenoble — Grenoble, France (NOT_YET_RECRUITING)
- Hôpital Claude Huriez — Lille, France (NOT_YET_RECRUITING)
- HCL - Hôpital Croix Rousse — Lyon, France (NOT_YET_RECRUITING)
- CHU de Marseille Hôpital de Timone — Marseille, France (NOT_YET_RECRUITING)
- l'Institut Paoli Calmettes — Marseille, France (NOT_YET_RECRUITING)
- CHU de Montpellier — Montpellier, France (NOT_YET_RECRUITING)
- CHU de Nancy - Hôpitaux Brabois — Nancy, France (NOT_YET_RECRUITING)
- Institut Mutualiste Montsouris — Paris, France (RECRUITING)
- Hôpital Cochin — Paris, France (RECRUITING)
- Hôpital La pitié Salpêtrière — Paris, France (RECRUITING)
- CHU de Reims — Reims, France (NOT_YET_RECRUITING)
- Hôpital Charles Nicolle — Rouen, France (NOT_YET_RECRUITING)
- CHU de Strasbourg - Nouvel Hôpital Civil — Strasbourg, France (NOT_YET_RECRUITING)
- CHU Rangueil — Toulouse, France (NOT_YET_RECRUITING)
- Hôpital Trousseau — Tours, France (NOT_YET_RECRUITING)
- Hôpital Paul Brousse — Villejuif, France (RECRUITING)
Study contacts
- Study coordinator: Caroline RIX
- Email: caroline.rix@imm.fr
- Phone: +33 156616371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Metastasis Colon Cancer, Postoperative Complications, Liver resection, Laparoscopy