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

Institut Mutualiste Montsouris

Status: Enrolling

Conditions: Postoperative Complications; Liver Metastasis Colon Cancer

Treatments: Procedure: hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04163887

DIG-03-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

340 participants in 2 patient groups

laparoscopic liver resection

Other group

Description:

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.

Treatment:

Procedure: hepatectomy

open liver resection

Other group

Description:

standard of care

Treatment:

Procedure: hepatectomy