Clinical trial NCT04163887: Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases
Official title: Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Metastasis Colon Cancer
Postoperative Complications
Keywords: Liver resection
Laparoscopy
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: National Cancer Institute, France
First posted: 2019-11-15
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective multicenter, open-label and pragmatic, controlled randomized (minimization procedure) superiority trial in 2 parallel groups comparing the rates of 90 days postoperative complications between patients undergoing laparoscopic and open liver resection for colorectal liver metastases.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: While laparotomy is still the standard approach of resectable colorectal liver mestastases, its associated morbidity remains non-negligible with reported mortality and complications rates ranging from 2 to 8% and 30 to 70%, respectively (1). Besides the underlying liver disease together with the comorbidities of the patients, this high morbidity is also related to the type of surgical approach. Since less than 15% of liver resections are currently performed using the laparoscopic approach in France, a trial showing the superiority of the laparoscopic approach in comparison to the open approach for patients with colorectal liver metastases qualifying for both approaches would allow improving management of patients, reducing the length of stay, maybe decreasing the global cost and changing current practices on a national scale.

In order to demonstrate the superiority of the laparoscopic approach over the laparotomy approach, patients with colorectal hepatic metastasis will be randomly assigned to either the laparoscopy or laparotomy groups. Post-operative complications (including mortality) will be measured using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization. The participation time for each patient in the study is 3 years, the patient will be followed at 1, 3, 6, 9, 9, 12, 15, 18, 21, 24, 30 and 36 months.

Eligibility 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.

Primary outcomes:
measure: Rate of overall complications using the comprehensive complication Index (CCI)
timeFrame: Within 90 days postoperatively or at any time during hospitalization.
Secondary outcomes:
measure: Proportion of patients presenting severe postoperative complications
timeFrame: Within 90 days postoperatively or at any time during hospitalization.
measure: Rate of conversion from laparoscopy liver resection to open liver surgery
timeFrame: during surgery.
measure: Length of hospital stay
timeFrame: Within 90 days postoperatively or at any time during hospitalization.
measure: Delay of recovery before resuming professional activities.
timeFrame: Within 90 days postoperatively
measure: Postoperative quality of life using quality of life questionnaries.
timeFrame: At the inclusion (before surgery), at 1 month postintervention, 3 months, 6 months and then every 6 months during 3 years.
measure: Health economics analysis
timeFrame: During the full participation period (3 years).
measure: Oncologic quality of the resection using the pathological report.
timeFrame: During surgery
measure: Disease-free and overall survival at 3 years.
timeFrame: During the full participation period (3 years).
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Caen
country: France
facility: Hôpital Côte de Nacre - Chu Caen
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Lyon
country: France
facility: HCL - Hôpital Croix Rousse
city: Marseille
country: France
facility: CHU de Marseille Hôpital de Timone
city: Marseille
country: France
facility: l'Institut Paoli Calmettes
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHU de Nancy - Hôpitaux Brabois
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital La pitié Salpêtrière
city: Reims
country: France
facility: CHU de Reims
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: CHU de Strasbourg - Nouvel Hôpital Civil
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: Hôpital Trousseau
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
affiliation: Institut Mutualiste Montsouris
name: David FUKS, PR
role: STUDY_CHAIR
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