Informations générales (source: ClinicalTrials.gov)

NCT04163887 En recrutement IDF
Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study (METALAP)
Interventional
  • Tumeurs du foie
  • Métastase tumorale
  • Complications postopératoires
N/A
Institut Mutualiste Montsouris (Voir sur ClinicalTrials)
janvier 2021
janvier 2026
29 juin 2024
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Beaujon François CAUCHY En recrutement IDF Contact (sur clinicalTrials)
AP-HP - Hôpital Cochin David FUKS En recrutement IDF Contact (sur clinicalTrials)
AP-HP - Hôpital Paul Brousse Daniel Cherqui En recrutement IDF Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Marseille Hôpital de Timone - Marseille - France Jean Hardwigsen Recrutement non commencé Contact (sur clinicalTrials)
CHU de Montpellier - Montpellier - France Jean-Michel Fabre Recrutement non commencé Contact (sur clinicalTrials)
CHU de Nancy - Hôpitaux Brabois - Nancy - France Ahmet Ayav Recrutement non commencé Contact (sur clinicalTrials)
CHU de Strasbourg - Nouvel Hôpital Civil - Strasbourg - France Patrick Pessaux Recrutement non commencé Contact (sur clinicalTrials)
CHU Estaing - Clermont-Ferrand - France Emmanuel Buc Recrutement non commencé Contact (sur clinicalTrials)
HCL - Hôpital Croix Rousse - Lyon - France Jean-Yves Mabrut Recrutement non commencé Contact (sur clinicalTrials)
Hôpital Charles Nicolle - Rouen - France Lilian Schwarz Recrutement non commencé Contact (sur clinicalTrials)
Hôpital Claude Huriez - Lille - France François-René Pruvot Recrutement non commencé Contact (sur clinicalTrials)
Hôpital Côte de Nacre - Chu Caen - Caen - France jean Lubrano Recrutement non commencé Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Amiens Picardie - Amiens - France Jean-Marc Regimbeau Recrutement non commencé Contact (sur clinicalTrials)
CHU de Grenoble - Grenoble - France Mircea Chirica Recrutement non commencé Contact (sur clinicalTrials)
CHU de Reims - Reims - France Reza Kianmanesh Recrutement non commencé Contact (sur clinicalTrials)
CHU Henri Mondor - Créteil - France Alexis Laurent En recrutement Contact (sur clinicalTrials)
CHU Rangueil - Toulouse - France Fabrice Muscari Recrutement non commencé Contact (sur clinicalTrials)
Hôpital La pitié Salpêtrière - Paris - France Olivier Scatton En recrutement Contact (sur clinicalTrials)
Hôpital Trousseau - Tours - France Ephrem Salamé Recrutement non commencé Contact (sur clinicalTrials)
Institut Mutualiste Montsouris - 75014 - Paris - France Ecoline TRIBILLON, Dr En recrutement Contact (sur clinicalTrials)
l'Institut Paoli Calmettes - Marseille - France Olivier Turrini Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous
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.


- 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.