Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases (METALAP)

February 21, 2022 updated by: Institut Mutualiste Montsouris

Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: laparoscopic liver resection
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.
Procedure: hepatectomy
Resection colorectal liver metastases using a laparoscopic approach or an open approach.
Other: open liver resection
standard of care
Procedure: hepatectomy
Resection colorectal liver metastases using a laparoscopic approach or an open approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of overall complications using the comprehensive complication Index (CCI)
Time Frame: Within 90 days postoperatively or at any time during hospitalization.
CCI is calculated using the burden of postoperative complications weighted with a measure of the severity according to the widely accepted Dindo-Clavien classification of postoperative complications and a dedicated CCI calculator.
Within 90 days postoperatively or at any time during hospitalization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients presenting severe postoperative complications
Time Frame: Within 90 days postoperatively or at any time during hospitalization.
Proportion of patients presenting severe postoperative complications rate as defined by the Clavien-Dindo classification ≥ grade 3 (including mortality) between patients treated with laparoscopic liver resection and those treated with open liver surgery
Within 90 days postoperatively or at any time during hospitalization.
Rate of conversion from laparoscopy liver resection to open liver surgery
Time Frame: during surgery.
Conversion is defined as the requirement for laparotomy at any time of the procedure with the exception of the extraction of the resected specimen. Specific data regarding conversion will be noticed from the operative reports. These included the reasons for conversion, the timing of conversion and the type of conversion.
during surgery.
Length of hospital stay
Time Frame: Within 90 days postoperatively or at any time during hospitalization.
Length of hospital stay and occurrence of unplanned readmission after discharge,assessed by hospitalization reports
Within 90 days postoperatively or at any time during hospitalization.
Delay of recovery before resuming professional activities.
Time Frame: Within 90 days postoperatively
Delay of recovery before resuming professional activities assessed by PQRS (Postoperative Quality Recovery Scale) including nociceptive domain, emotional domain, cognition domain and day-to-day activities at D-1, D1, D7, D30 and D90.
Within 90 days postoperatively
Postoperative quality of life using quality of life questionnaries.
Time Frame: At the inclusion (before surgery), at 1 month postintervention, 3 months, 6 months and then every 6 months during 3 years.
Patient-reported outcome measures were assessed with the validated European Organisation for Research and Treatment of Cancer (EORTC) score questionnaire, EORTC Quality of Life Questionnaire (QLQ) -C30 (version 3.0), and the module dedicated to colorectal liver metastases (EORTC QLQ-LMC21). EQ5D-5L is a standardised measure of health status that provides a simple descriptive profile and a single index value suitable for the economic evaluation of health. It will be used to calculate the QALYs of each enrolled patient, by valuing health.
At the inclusion (before surgery), at 1 month postintervention, 3 months, 6 months and then every 6 months during 3 years.
Health economics analysis
Time Frame: During the full participation period (3 years).

A cost-effectiveness study will be performed and completed by a cost-utility analysis to identify the efficient therapeutic strategy (laparoscopic approach) ompared to the reference (open surgery).

Only direct costs will be considered for treatments, management of side effects, medical transports, rehabilitation procedures and medical consultations.

Out of hospital resources are valued from the Social Health Insurance (SHI) tariffs and hospital stays the Diagnosis-Related group (DRG) tariff taking into account additional daily fixed prices for ICU stay, if any.
During the full participation period (3 years).
Oncologic quality of the resection using the pathological report.
Time Frame: During surgery
Mean surgical margin widths (in millimeters). Percentages of microscopically complete (R0), microscopically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.
During surgery
Disease-free and overall survival at 3 years.
Time Frame: During the full participation period (3 years).
  1. Percentage of patients with intrahepatic or extrahepatic recurrence three years after the operation.
  2. Median disease-free survival time (in months).
  3. Percentage of patients who died at 1, 2 and 3 years after the procedure.
  4. Median overall survival time (in months).
During the full participation period (3 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Mutualiste Montsouris

Collaborators

Ministry of Health, France
National Cancer Institute, France

Investigators

  • Study Chair: David FUKS, PR, Institut Mutualiste Montsouris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Anticipated)

April 27, 2023

Study Completion (Anticipated)

January 27, 2026

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIG-03-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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