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JOURNAL ONKOLOGIE – STUDIE
LIVACOR

LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

Rekrutierend

NCT-Nummer:
NCT05138094

Studienbeginn:
August 2021

Letztes Update:
25.07.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Neoplasm Metastasis, Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Fondazione Poliambulanza Istituto Ospedaliero

Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Hospital Southampton NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, King's College Hospital NHS Trus

Studienleiter

Professor Mohammed Abu Hilal, MD PhD
Study Chair
Fondazione Poliambulanza Istituto Ospedaliero

Kontakt

Studienlocations
(3 von 28)

Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
66119 Saarbrücken
(Saarland)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Gregor Stavrou, MD» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Time to functional recovery (Time Frame - Expected average of 4 to 12 days postoperatively):
A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met.



Secondary outcome:

1. R0 resection margin (Time Frame - 30 days postoperatively):
Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.

2. Length of hospital stay (Time Frame - 30 days postoperatively):
The length of hospital stay for the surgical procedure(s)

3. Activity tracking using Fitbit™ (Time Frame - 14 days pre-operatively and 60 days postoperatively):
A patient's functional recovery will also be assessed using the Fitbit smartwatch.

4. Intraoperative blood loss (Time Frame - During the surgical procedure):
Intraoperative blood loss in milliliters

5. Operative time (Time Frame - Operative time from incision until last suture):
Operative time in minutes

6. Morbidity (Time Frame - 90-days postoperatively):
Morbidity related to the surgical procedure(s)

7. Postoperative bile leakage (Time Frame - 90-days postoperatively):
Bile leakage occurring after the liver resection

8. Postoperative anastomotic leakage (Time Frame - 90-days postoperatively):
Anastomotic leakage occurring after the colorectal resection

9. Conversion to open surgery (Time Frame - During the surgical procedure):
Intra-operative conversion to an open or hand-assisted procedure

10. Readmission rate (Time Frame - 90-days postoperatively):
Proportion of patients who is unexpectedly readmitted after the surgical procedure(s)

11. Health-Related Quality of Life (Time Frame - 1 year postoperatively):
The physical, social and emotional well-being of the patient; assessed using the EuroQol 5d and European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 instruments.

12. Reasons for delay of discharge after functional recovery (Time Frame - 30 days postoperatively):
All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.

13. Hospital and societal costs (Time Frame - 1 year postoperatively):
All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.

14. Three and five-year recurrence free survival (Time Frame - 5 years postoperatively):
The proportion of patients which is free of recurrence of the malignant disease after resection of both the primary colorectal carcinoma and the liver metastases.

15. Three and five-year overall survival (Time Frame - 5 years postoperatively):
The proportion of patients which is alive after resection of both the primary colorectal carcinoma and the liver metastases.

Studien-Arme

  • Active Comparator: Minimally invasive two-stage resection
    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.
  • Experimental: Minimally invasive simultaneous resection
    Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure.

Geprüfte Regime

  • Minimally invasive simultaneous resection (Minimally invasive combined resection / Minimally invasive synchronous resection / ):
    One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.
  • Minimally invasive two-stage resection (Minimally invasive sequential resection):
    Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed

Quelle: ClinicalTrials.gov


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