LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

Fondazione Poliambulanza Istituto Ospedaliero

Status: Enrolling

Conditions: Colorectal Neoplasms Malignant; Neoplasm Metastasis

Treatments: Procedure: Minimally invasive two-stage resection; Procedure: Minimally invasive simultaneous resection

Study type: Interventional

Funder types: Other

Identifiers

NCT05138094

NP3969

Details and patient eligibility

About

The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years

• Diagnosed with primary CRC with resectable synchronous CRLMs (with or without neoadjuvant chemotherapy)*

• Elective indication for MI combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to 3 segments with a maximum of 2 separate liver resections. The MI two-staged approach includes both the conventional strategy (first resection of primary colorectal tumor followed by liver resection for CRLMs) and liver-first strategy (first CRLMs resection followed by resection of colorectal primary tumor). Patients undergoing bilobar resections are eligible (if 3 or fewer segments are resected)

• BMI between and including 18-35

• Patients with American Society of Anesthesiologists (ASA) physical status I-III and the American College of Surgeons national surgical quality improvement project (ACS NSQIP) universal surgical risk score of ≤ 50% for serious complications

  • In case of neoadjuvant chemotherapy, time interval between last chemotherapy cycle and (first) surgery should be 4-6 weeks.

Exclusion criteria

• Inability to give (written) informed consent.
• Patients requiring a planned temporarily or permanent stoma after colorectal resection (all colectomies, including high anterior resection). Patients who will receive an unplanned stoma intraoperatively, will be analysed according to their initial treatment assignment.
• Patients requiring multivisceral colorectal resection (all colectomies, including high anterior resection).
• Indication for MI combined or staged low anterior resection, total mesorectal excision or abdominoperineal resection and liver resection of four or more segments (i.e., hemihepatectomy or more extensive resections).
• Patients with peritoneal metastases.
• Patients with ASA physical status IV-V and ACS NSQIP surgical risk score of > 50% for serious complications.
• Repeat open hepatectomy
• Surgical history of colorectal- or liver resection for neoplastic disease
• Surgical history of major or complicated open abdominal surgery
• Indication for concurrent thermal ablation
• Medical history of thermal ablation of liver for malignancy
• Unresectable extrahepatic metastases
• Pre-operatively reconstruction of vessels/bile ducts is deemed necessary

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Minimally invasive two-stage resection

Active Comparator group

Description:

Minimally invasive resection of the primary colorectal carcinoma and liver metastases in two stages. The liver metastases or the colorectal carcinoma can be resected during the first surgical procedure.

Treatment:

Procedure: Minimally invasive two-stage resection

Minimally invasive simultaneous resection

Experimental group

Description:

Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure.

Treatment:

Procedure: Minimally invasive simultaneous resection