LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05138094
• Collaborator: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), University Hospital Southampton NHS Foundation Trust (Other), University Hospital Birmingham NHS Foundation Trust (Other), Liverpool University Hospitals NHS Foundation Trust (Other), King's College Hospital NHS Trust (Other), Manchester University NHS Foundation Trust (Other), Newcastle-upon-Tyne Hospitals NHS Trust (Other), University Hospital Plymouth NHS Trust (Other), Mauriziano Umberto I Hospital (Other), University Hospital Padova (Other), Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other), San Raffaele University Hospital, Italy (Other), Ospedali Riuniti Ancona (Other), Azienda Usl di Bologna (Other), Azienda Ospedaliero-Universitaria di Modena (Other), Federico II University (Other), Parma University Hospital (Other), Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie (Other), Maastricht University Medical Center (Other), University of Navarrra Hospital (Clinica Universitaria) (Other), Hospital del Mar (Other), Assistance Publique - Hôpitaux de Paris (Other), Oslo University Hospital (Other), Ziekenhuis Oost-Limburg (Other), General Hospital Groeninge (Other), Moscow Clinical Scientific Center (Other), Centre Hospitalier du Luxembourg (Other)
• Enrollment: 82
• Locations: 28
• Arms: 2
• Anticipated Duration (Months): 36.9
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Malignant; Neoplasm Metastasis	Procedure: Minimally invasive simultaneous resection; Procedure: Minimally invasive two-stage resection	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
• Actual Study Start Date: Aug 6, 2021
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: Minimally invasive two-stage resection; Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed; Other Names: Minimally invasive sequential resection
Experimental: Minimally invasive simultaneous resection Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure.	Procedure: Minimally invasive simultaneous resection; One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.; Other Names: Minimally invasive combined resection Minimally invasive synchronous resection

Outcome Measures

Primary Outcome Measures

1. Time to functional recovery [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 Measures

1. R0 resection margin [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 [30 days postoperatively]

   The length of hospital stay for the surgical procedure(s)

3. Activity tracking using Fitbit™ [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 [During the surgical procedure]

   Intraoperative blood loss in milliliters

5. Operative time [Operative time from incision until last suture]

   Operative time in minutes

6. Morbidity [90-days postoperatively]

   Morbidity related to the surgical procedure(s)

7. Postoperative bile leakage [90-days postoperatively]

   Bile leakage occurring after the liver resection

8. Postoperative anastomotic leakage [90-days postoperatively]

   Anastomotic leakage occurring after the colorectal resection

9. Conversion to open surgery [During the surgical procedure]

   Intra-operative conversion to an open or hand-assisted procedure

10. Readmission rate [90-days postoperatively]

    Proportion of patients who is unexpectedly readmitted after the surgical procedure(s)

11. Health-Related Quality of Life [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 [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 [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 [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 [5 years postoperatively]

    The proportion of patients which is alive after resection of both the primary colorectal carcinoma and the liver metastases.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziekenhuis Oost-Limburg	Genk	Limburg	Belgium	3600
2	General Hospital Groeninge	Kortrijk	West Flanders	Belgium	8500
3	Antoine-Béclère Hospital	Paris	Île-de-France	France	92140
4	Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie	Saarbrücken	Saarland	Germany	66119
5	Federico II University Hospital	Naples	Calabria	Italy	80131
6	Azienda USL di Bologna	Bologna	Emilia-Romagna	Italy	40124
7	Azienda Ospedaliero-Universitaria di Modena	Modena	Emilia-Romagna	Italy	41125
8	Parma University Hospital	Parma	Emilia-Romagna	Italy	43126
9	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio	Italy	00168
10	Fondazione Poliambulanza Istituto Ospedaliero	Brescia	Lombardy	Italy	25124
11	San Raffaele University Hospital	Milan	Lombardy	Italy	20132
12	Ospedali Riuniti	Ancona	Marche	Italy	60126
13	Mauriziano Umberto I Hospital	Turin	Piemonte	Italy	10128
14	University Hospital Padova	Padova	Veneto	Italy	35128
15	Centre Hospitalier du Luxembourg	Luxembourg		Luxembourg	L-1210
16	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6229 HX
17	Amsterdam UMC	Amsterdam	Noord-Holland	Netherlands	1081 HV
18	Oslo University Hospital	Oslo	Østlandet	Norway	N-0424
19	Moscow Clinical Scientific Center	Moscow	Moscow Oblast	Russian Federation	111123
20	Hospital del Mar	Barcelona	Catalonia	Spain	08003
21	University of Navarrra Hospital (Clinica Universitaria)	Pamplona	Navarre	Spain	31008
22	Manchester University NHS Foundation Trust	Manchester	North West England	United Kingdom	M13 9WL
23	Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle	Northeast England	United Kingdom	NE1 4LP
24	Liverpool University Hospitals NHS Foundation Trust	Liverpool	Northwest England	United Kingdom	L7 8XP
25	University Hospital Southampton NHS Foundation Trust	Southampton	South East England	United Kingdom	SO16 6YD
26	King's College Hospital NHS Trust	London	Southeast England	United Kingdom	SE5 9RS
27	University Hospital Plymouth NHS Trust	Plymouth	Southwest England	United Kingdom	PL6 8DH
28	University Hospital Birmingham NHS Foundation Trust	Birmingham	West Midlands	United Kingdom	B15 1NT

Sponsors and Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero
• 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 Trust
• Manchester University NHS Foundation Trust
• Newcastle-upon-Tyne Hospitals NHS Trust
• University Hospital Plymouth NHS Trust
• Mauriziano Umberto I Hospital
• University Hospital Padova
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• San Raffaele University Hospital, Italy
• Ospedali Riuniti Ancona
• Azienda Usl di Bologna
• Azienda Ospedaliero-Universitaria di Modena
• Federico II University
• Parma University Hospital
• Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
• Maastricht University Medical Center
• University of Navarrra Hospital (Clinica Universitaria)
• Hospital del Mar
• Assistance Publique - Hôpitaux de Paris
• Oslo University Hospital
• Ziekenhuis Oost-Limburg
• General Hospital Groeninge
• Moscow Clinical Scientific Center
• Centre Hospitalier du Luxembourg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Boudjema K, Locher C, Sabbagh C, Ortega-Deballon P, Heyd B, Bachellier P, Métairie S, Paye F, Bourlier P, Adam R, Merdrignac A, Tual C, Le Pabic E, Sulpice L, Meunier B, Regimbeau JM, Bellissant E; METASYNC Study group. Simultaneous Versus Delayed Resection for Initially Resectable Synchronous Colorectal Cancer Liver Metastases: A Prospective, Open-label, Randomized, Controlled Trial. Ann Surg. 2021 Jan 1;273(1):49-56. doi: 10.1097/SLA.0000000000003848.
• Gavriilidis P, Sutcliffe RP, Hodson J, Marudanayagam R, Isaac J, Azoulay D, Roberts KJ. Simultaneous versus delayed hepatectomy for synchronous colorectal liver metastases: a systematic review and meta-analysis. HPB (Oxford). 2018 Jan;20(1):11-19. doi: 10.1016/j.hpb.2017.08.008. Epub 2017 Sep 7.
• Pan L, Tong C, Fu S, Fang J, Gu Q, Wang S, Jiang Z, Juengpanich S, Cai X. Laparoscopic procedure is associated with lower morbidity for simultaneous resection of colorectal cancer and liver metastases: an updated meta-analysis. World J Surg Oncol. 2020 Sep 21;18(1):251. doi: 10.1186/s12957-020-02018-z.
• van der Poel MJ, Tanis PJ, Marsman HA, Rijken AM, Gertsen EC, Ovaere S, Gerhards MF, Besselink MG, D'Hondt M, Gobardhan PD. Laparoscopic combined resection of liver metastases and colorectal cancer: a multicenter, case-matched study using propensity scores. Surg Endosc. 2019 Apr;33(4):1124-1130. doi: 10.1007/s00464-018-6371-1. Epub 2018 Aug 1.

• Responsible Party: Fondazione Poliambulanza Istituto Ospedaliero
• ClinicalTrials.gov Identifier: NCT05138094
• Other Study ID Numbers: NP3969
• First Posted: Nov 30, 2021
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms

Study Results

No Results Posted as of Jul 25, 2022