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

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ClinicalTrials.gov Identifier: NCT04163887
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : February 22, 2022
Sponsor:
Collaborators:
Ministry of Health, France
National Cancer Institute, France
Information provided by (Responsible Party):
Institut Mutualiste Montsouris

Tracking Information
First Submitted Date  ICMJE October 21, 2019
First Posted Date  ICMJE November 15, 2019
Last Update Posted Date February 22, 2022
Actual Study Start Date  ICMJE January 27, 2021
Estimated Primary Completion Date April 27, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2019)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2019)
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases
Official Title  ICMJE Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Metastasis Colon Cancer
  • Postoperative Complications
Intervention  ICMJE Procedure: hepatectomy
Resection colorectal liver metastases using a laparoscopic approach or an open approach.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: hepatectomy
  • open liver resection
    standard of care
    Intervention: Procedure: hepatectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2019)		 340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 27, 2026
Estimated Primary Completion Date April 27, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Caroline RIX +33 156616371 caroline.rix@imm.fr
Contact: Nassima OUDAFAL +33 156616675 nassima.oudafal@imm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04163887
Other Study ID Numbers  ICMJE DIG-03-2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Institut Mutualiste Montsouris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut Mutualiste Montsouris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Ministry of Health, France
  • National Cancer Institute, France
Investigators  ICMJE
Study Chair: David FUKS, PR Institut Mutualiste Montsouris
PRS Account Institut Mutualiste Montsouris
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP