Back to resultsLIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection (LIVACOR)
Primary Purpose
Colorectal Neoplasms Malignant, Neoplasm Metastasis
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Minimally invasive simultaneous resection
Minimally invasive two-stage resection
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms Malignant
Eligibility Criteria
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
Sites / Locations
- Ziekenhuis Oost-Limburg
- General Hospital GroeningeRecruiting
- Antoine-Béclère Hospital
- Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische OnkologieRecruiting
- Federico II University Hospital
- Azienda USL di BolognaRecruiting
- Azienda Ospedaliero-Universitaria di Modena
- Parma University Hospital
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
- Fondazione Poliambulanza Istituto OspedalieroRecruiting
- San Raffaele University Hospital
- Ospedali Riuniti
- Mauriziano Umberto I Hospital
- University Hospital PadovaRecruiting
- Centre Hospitalier du LuxembourgRecruiting
- Maastricht University Medical Center
- Amsterdam UMCRecruiting
- Oslo University HospitalRecruiting
- Moscow Clinical Scientific CenterRecruiting
- Hospital del MarRecruiting
- University of Navarrra Hospital (Clinica Universitaria)
- Manchester University NHS Foundation Trust
- Newcastle-upon-Tyne Hospitals NHS Trust
- Liverpool University Hospitals NHS Foundation Trust
- University Hospital Southampton NHS Foundation Trust
- King's College Hospital NHS Trust
- University Hospital Plymouth NHS Trust
- University Hospital Birmingham NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Minimally invasive two-stage resection
Minimally invasive simultaneous resection
Arm 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.
Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure.
Outcomes
Primary Outcome Measures
Time to functional recovery
A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met.
Secondary Outcome Measures
R0 resection margin
Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.
Length of hospital stay
The length of hospital stay for the surgical procedure(s)
Activity tracking using Fitbit™
A patient's functional recovery will also be assessed using the Fitbit smartwatch.
Intraoperative blood loss
Intraoperative blood loss in milliliters
Operative time
Operative time in minutes
Morbidity
Morbidity related to the surgical procedure(s)
Postoperative bile leakage
Bile leakage occurring after the liver resection
Postoperative anastomotic leakage
Anastomotic leakage occurring after the colorectal resection
Conversion to open surgery
Intra-operative conversion to an open or hand-assisted procedure
Readmission rate
Proportion of patients who is unexpectedly readmitted after the surgical procedure(s)
Health-Related Quality of Life
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.
Reasons for delay of discharge after functional recovery
All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.
Hospital and societal costs
All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.
Three and five-year recurrence free survival
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.
Three and five-year overall survival
The proportion of patients which is alive after resection of both the primary colorectal carcinoma and the liver metastases.
Full Information
NCT ID
NCT05138094
First Posted
November 5, 2021
Last Updated
July 22, 2022
Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT05138094
Brief Title
LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
Acronym
LIVACOR
Official Title
LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms Malignant, Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minimally invasive two-stage resection
Arm Type
Active Comparator
Arm 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.
Arm Title
Minimally invasive simultaneous resection
Arm Type
Experimental
Arm Description
Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive simultaneous resection
Other Intervention Name(s)
Minimally invasive combined resection, Minimally invasive synchronous resection
Intervention Description
One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive two-stage resection
Other Intervention Name(s)
Minimally invasive sequential resection
Intervention Description
Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed
Primary Outcome Measure Information:
Title
Time to functional recovery
Description
A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met.
Time Frame
Expected average of 4 to 12 days postoperatively
Secondary Outcome Measure Information:
Title
R0 resection margin
Description
Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.
Time Frame
30 days postoperatively
Title
Length of hospital stay
Description
The length of hospital stay for the surgical procedure(s)
Time Frame
30 days postoperatively
Title
Activity tracking using Fitbit™
Description
A patient's functional recovery will also be assessed using the Fitbit smartwatch.
Time Frame
14 days pre-operatively and 60 days postoperatively
Title
Intraoperative blood loss
Description
Intraoperative blood loss in milliliters
Time Frame
During the surgical procedure
Title
Operative time
Description
Operative time in minutes
Time Frame
Operative time from incision until last suture
Title
Morbidity
Description
Morbidity related to the surgical procedure(s)
Time Frame
90-days postoperatively
Title
Postoperative bile leakage
Description
Bile leakage occurring after the liver resection
Time Frame
90-days postoperatively
Title
Postoperative anastomotic leakage
Description
Anastomotic leakage occurring after the colorectal resection
Time Frame
90-days postoperatively
Title
Conversion to open surgery
Description
Intra-operative conversion to an open or hand-assisted procedure
Time Frame
During the surgical procedure
Title
Readmission rate
Description
Proportion of patients who is unexpectedly readmitted after the surgical procedure(s)
Time Frame
90-days postoperatively
Title
Health-Related Quality of Life
Description
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.
Time Frame
1 year postoperatively
Title
Reasons for delay of discharge after functional recovery
Description
All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.
Time Frame
30 days postoperatively
Title
Hospital and societal costs
Description
All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.
Time Frame
1 year postoperatively
Title
Three and five-year recurrence free survival
Description
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.
Time Frame
5 years postoperatively
Title
Three and five-year overall survival
Description
The proportion of patients which is alive after resection of both the primary colorectal carcinoma and the liver metastases.
Time Frame
5 years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jasper Sijberden, MD
Phone
0031630150451
Email
jasper.sijberden@poliambulanza.it
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Mohammed Abu Hilal, MD PhD
Email
abuhilal9@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Mohammed Abu Hilal, MD PhD
Organizational Affiliation
Fondazione Poliambulanza Istituto Ospedaliero
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Wicherts, PhD
First Name & Middle Initial & Last Name & Degree
Dennis Wicherts, PhD
First Name & Middle Initial & Last Name & Degree
Joep Knol, PhD
Facility Name
General Hospital Groeninge
City
Kortrijk
State/Province
West Flanders
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu D'Hondt, PhD
First Name & Middle Initial & Last Name & Degree
Mathieu D'Hondt, PhD
First Name & Middle Initial & Last Name & Degree
Bart van Geluwe, PhD
Facility Name
Antoine-Béclère Hospital
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
92140
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Dagher, PhD
First Name & Middle Initial & Last Name & Degree
Ibrahim Dagher, PhD
First Name & Middle Initial & Last Name & Degree
Panagiotis Lainas, PhD
Facility Name
Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66119
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregor Stavrou, MD
First Name & Middle Initial & Last Name & Degree
Gregor Stavrou, MD
Facility Name
Federico II University Hospital
City
Naples
State/Province
Calabria
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Troisi, PhD
First Name & Middle Initial & Last Name & Degree
Roberto Troisi, PhD
First Name & Middle Initial & Last Name & Degree
Gaetano Luglio, PhD
Facility Name
Azienda USL di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elio Jovine, PhD
First Name & Middle Initial & Last Name & Degree
Elio Jovine, PhD
First Name & Middle Initial & Last Name & Degree
Michele Masetti, MD
First Name & Middle Initial & Last Name & Degree
Simone Nicosia, MD
Facility Name
Azienda Ospedaliero-Universitaria di Modena
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41125
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio di Benedetto, PhD
First Name & Middle Initial & Last Name & Degree
Fabrizio di Benedetto, PhD
First Name & Middle Initial & Last Name & Degree
Paolo Magistri, MD
Facility Name
Parma University Hospital
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Dalla Valle, PhD
First Name & Middle Initial & Last Name & Degree
Raffaele Dalla Valle, PhD
First Name & Middle Initial & Last Name & Degree
Mario Giuffrida, MD
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felice Giuliante, PhD
First Name & Middle Initial & Last Name & Degree
Felice Giuliante, PhD
First Name & Middle Initial & Last Name & Degree
Roberto Persiani, PhD
Facility Name
Fondazione Poliambulanza Istituto Ospedaliero
City
Brescia
State/Province
Lombardy
ZIP/Postal Code
25124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Abu Hilal, PhD
First Name & Middle Initial & Last Name & Degree
Mohammed Abu Hilal, PhD
First Name & Middle Initial & Last Name & Degree
Jasper Sijberden, MD
Facility Name
San Raffaele University Hospital
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Aldrighetti, PhD
First Name & Middle Initial & Last Name & Degree
Luca Aldrighetti, PhD
Facility Name
Ospedali Riuniti
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Vivarelli, PhD
First Name & Middle Initial & Last Name & Degree
Marco Vivarelli, PhD
First Name & Middle Initial & Last Name & Degree
Mario Guerrieri, PhD
First Name & Middle Initial & Last Name & Degree
Andrea Benedetti Cacciaguerra, MD
Facility Name
Mauriziano Umberto I Hospital
City
Turin
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Ferrero, PhD
First Name & Middle Initial & Last Name & Degree
Alessandro Ferrero, PhD
First Name & Middle Initial & Last Name & Degree
Paolo Massucco, MD
Facility Name
University Hospital Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, PhD
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, PhD
First Name & Middle Initial & Last Name & Degree
Enrico Gringeri, PhD
First Name & Middle Initial & Last Name & Degree
Jacopo Lanari, MD
Facility Name
Centre Hospitalier du Luxembourg
City
Luxembourg
ZIP/Postal Code
L-1210
Country
Luxembourg
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edoardo Rosso, MD
First Name & Middle Initial & Last Name & Degree
Edoardo Rosso, MD
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald van Dam, PhD
First Name & Middle Initial & Last Name & Degree
Ronald van Dam, PhD
First Name & Middle Initial & Last Name & Degree
Jarno Melenhorst, PhD
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rutger-Jan Swijnenburg, PhD
First Name & Middle Initial & Last Name & Degree
Rutger-Jan Swijnenburg, PhD
Facility Name
Oslo University Hospital
City
Oslo
State/Province
Østlandet
ZIP/Postal Code
N-0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjørn Edwin, PhD
First Name & Middle Initial & Last Name & Degree
Bjørn Edwin, PhD
First Name & Middle Initial & Last Name & Degree
Sheraz Yaqub, PhD
First Name & Middle Initial & Last Name & Degree
Asmund Fretland, PhD
Facility Name
Moscow Clinical Scientific Center
City
Moscow
State/Province
Moscow Oblast
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail Efanov, PhD
First Name & Middle Initial & Last Name & Degree
Mikhail Efanov, PhD
First Name & Middle Initial & Last Name & Degree
Mikhail Danilov, PhD
First Name & Middle Initial & Last Name & Degree
Aslan Baychorov, PhD
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedetto Ielpo, PhD
First Name & Middle Initial & Last Name & Degree
Benedetto Ielpo, PhD
Facility Name
University of Navarrra Hospital (Clinica Universitaria)
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Rotellar, PhD
First Name & Middle Initial & Last Name & Degree
Fernando Rotellar, PhD
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
State/Province
North West England
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aali Sheen, PhD
First Name & Middle Initial & Last Name & Degree
Aali Sheen, PhD
Facility Name
Newcastle-upon-Tyne Hospitals NHS Trust
City
Newcastle
State/Province
Northeast England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve White, PhD
First Name & Middle Initial & Last Name & Degree
Steve White, PhD
Facility Name
Liverpool University Hospitals NHS Foundation Trust
City
Liverpool
State/Province
Northwest England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Díaz-Nieto, PhD
First Name & Middle Initial & Last Name & Degree
Rafael Díaz-Nieto, PhD
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
South East England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Primrose, PhD
First Name & Middle Initial & Last Name & Degree
John Primrose, PhD
First Name & Middle Initial & Last Name & Degree
Alex Mirnezami, PhD
Facility Name
King's College Hospital NHS Trust
City
London
State/Province
Southeast England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishna Menon, PhD
First Name & Middle Initial & Last Name & Degree
Krishna Menon, PhD
First Name & Middle Initial & Last Name & Degree
Amyn Haji, MD
Facility Name
University Hospital Plymouth NHS Trust
City
Plymouth
State/Province
Southwest England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somaiah Aroori, PhD
First Name & Middle Initial & Last Name & Degree
Somaiah Aroori, PhD
Facility Name
University Hospital Birmingham NHS Foundation Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 1NT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Sutcliffe, MD
First Name & Middle Initial & Last Name & Degree
Robert Sutcliffe, MD
First Name & Middle Initial & Last Name & Degree
Shazad Ashraf, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30069639
Citation
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.
Results Reference
background
PubMed Identifier
32958079
Citation
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.
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PubMed Identifier
32209911
Citation
Boudjema K, Locher C, Sabbagh C, Ortega-Deballon P, Heyd B, Bachellier P, Metairie 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.
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PubMed Identifier
28888775
Citation
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.
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LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
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