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ClinicalTrials.gov ID

NCT04163887

Lead Sponsor

Institut Mutualiste MontsourisOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

340Estimated

Last Update Posted

Feb 22, 2022Actual

Start Date

Jan 27, 2021Actual

Primary Completion Date

Apr 27, 2023Estimated

Completion Date

Jan 27, 2026Estimated

Official Title

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.

• Liver Metastasis Colon Cancer
• Postoperative Complications

• hepatectomy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Institut Mutualiste MontsourisOTHER

Collaborators

Ministry of Health, FranceOTHER_GOV

National Cancer Institute, FranceOTHER_GOV

francois.cauchy@aphp.fr

david.fuks@aphp.fr