LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection (LIVACOR)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    82
  • sponsor
    Fondazione Poliambulanza Istituto Ospedaliero
Updated on 4 October 2022
carcinoma

Summary

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.

Details
Condition Colorectal Neoplasms Malignant, Neoplasm Metastasis
Treatment Minimally invasive simultaneous resection, Minimally invasive two-stage resection
Clinical Study IdentifierNCT05138094
SponsorFondazione Poliambulanza Istituto Ospedaliero
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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