Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases
NCT ID: NCT04163887
Last Updated: 2022-02-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
340 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-27
Study Completion Date
2026-01-27
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Liver Metastasis Colon Cancer
Postoperative Complications
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
OTHER
hepatectomy
Intervention Type
PROCEDURE
Resection colorectal liver metastases using a laparoscopic approach or an open approach.
open liver resection
standard of care
Group Type
OTHER
hepatectomy
Intervention Type
PROCEDURE
Resection colorectal liver metastases using a laparoscopic approach or an open approach.
Interventions
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hepatectomy
Resection colorectal liver metastases using a laparoscopic approach or an open approach.
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Sponsor Role
collaborator
National Cancer Institute, France
OTHER_GOV
Sponsor Role
collaborator
Institut Mutualiste Montsouris
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David FUKS, PR
Role: STUDY_CHAIR
Institut Mutualiste Montsouris
Locations
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CHU Amiens Picardie
Amiens, , France
Site Status
NOT_YET_RECRUITING
Hôpital Côte de Nacre - Chu Caen
Caen, , France
Site Status
NOT_YET_RECRUITING
CHU Estaing
Clermont-Ferrand, , France
Site Status
NOT_YET_RECRUITING
Hôpital Beaujon
Clichy, , France
Site Status
RECRUITING
CHU Henri Mondor
Créteil, , France
Site Status
RECRUITING
CHU de Grenoble
Grenoble, , France
Site Status
NOT_YET_RECRUITING
Hôpital Claude Huriez
Lille, , France
Site Status
NOT_YET_RECRUITING
HCL - Hôpital Croix Rousse
Lyon, , France
Site Status
NOT_YET_RECRUITING
CHU de Marseille Hôpital de Timone
Marseille, , France
Site Status
NOT_YET_RECRUITING
l'Institut Paoli Calmettes
Marseille, , France
Site Status
NOT_YET_RECRUITING
CHU de Montpellier
Montpellier, , France
Site Status
NOT_YET_RECRUITING
CHU de Nancy - Hôpitaux Brabois
Nancy, , France
Site Status
NOT_YET_RECRUITING
Institut Mutualiste Montsouris
Paris, , France
Site Status
RECRUITING
Hôpital Cochin
Paris, , France
Site Status
RECRUITING
Hôpital La pitié Salpêtrière
Paris, , France
Site Status
RECRUITING
CHU de Reims
Reims, , France
Site Status
NOT_YET_RECRUITING
Hôpital Charles Nicolle
Rouen, , France
Site Status
NOT_YET_RECRUITING
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, , France
Site Status
NOT_YET_RECRUITING
CHU Rangueil
Toulouse, , France
Site Status
NOT_YET_RECRUITING
Hôpital Trousseau
Tours, , France
Site Status
NOT_YET_RECRUITING
Hôpital Paul Brousse
Villejuif, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DIG-03-2019
Identifier Type: -
Identifier Source: org_study_id
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