Colorectal Neoplasms MalignantLIVACORNCT05138094
LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
A study testing Minimally invasive simultaneous resection and Minimally invasive two-stage resection in people with Colorectal Neoplasms Malignant and Neoplasm Metastasis, run by Fondazione Poliambulanza Istituto Ospedaliero at 28 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms Malignant, Neoplasm Metastasis
- What is being tested?
- Minimally invasive simultaneous resection and Minimally invasive two-stage resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 28 sitesin 10 countries
- Study dates
- 6 Aug 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
28 sites in 10 countries.
Professor Mohammed Abu Hilal, MD PhD contact
28 sites in 10 countries
Italy10 sites, 10 recruiting
- Not yet recruiting
Ospedali Riuniti
Ancona, The Marches, 60126
Marco Vivarelli, PhD
Marco Vivarelli, PhD
- Recruiting
Azienda USL di Bologna
Bologna, Emilia-Romagna, 40124
Elio Jovine, PhD
Elio Jovine, PhD
- Recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, 25124
Mohammed Abu Hilal, PhD
Mohammed Abu Hilal, PhD
- Not yet recruiting
San Raffaele University Hospital
Milan, Lombardy, 20132
Luca Aldrighetti, PhD
Luca Aldrighetti, PhD
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena, Emilia-Romagna, 41125
Fabrizio di Benedetto, PhD
Fabrizio di Benedetto, PhD
- Not yet recruiting
Federico II University Hospital
Naples, Calabria, 80131
Roberto Troisi, PhD
Roberto Troisi, PhD
- Recruiting
University Hospital Padova
Padova, Veneto, 35128
Umberto Cillo, PhD
Umberto Cillo, PhD
- Not yet recruiting
Parma University Hospital
Parma, Emilia-Romagna, 43126
Raffaele Dalla Valle, PhD
Raffaele Dalla Valle, PhD
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
Felice Giuliante, PhD
Felice Giuliante, PhD
- Not yet recruiting
Mauriziano Umberto I Hospital
Turin, Piedmont, 10128
Alessandro Ferrero, PhD
Alessandro Ferrero, PhD
United Kingdom7 sites, 7 recruiting
- Not yet recruiting
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 1NT
Robert Sutcliffe, MD
Robert Sutcliffe, MD
- Not yet recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Northwest England, L7 8XP
Rafael Díaz-Nieto, PhD
Rafael Díaz-Nieto, PhD
- Not yet recruiting
King's College Hospital NHS Trust
London, Southeast England, SE5 9RS
Krishna Menon, PhD
Krishna Menon, PhD
- Not yet recruiting
Manchester University NHS Foundation Trust
Manchester, North West England, M13 9WL
Aali Sheen, PhD
Aali Sheen, PhD
- Not yet recruiting
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle, Northeast England, NE1 4LP
Steve White, PhD
Steve White, PhD
- Not yet recruiting
University Hospital Plymouth NHS Trust
Plymouth, Southwest England, PL6 8DH
Somaiah Aroori, PhD
Somaiah Aroori, PhD
- Not yet recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, South East England, SO16 6YD
John Primrose, PhD
John Primrose, PhD
Belgium2 sites, 2 recruiting
- Not yet recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Dennis Wicherts, PhD
Dennis Wicherts, PhD
- Recruiting
General Hospital Groeninge
Kortrijk, West Flanders, 8500
Mathieu D'Hondt, PhD
Mathieu D'Hondt, PhD
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1081 HV
Rutger-Jan Swijnenburg, PhD
Rutger-Jan Swijnenburg, PhD
- Not yet recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Ronald van Dam, PhD
Ronald van Dam, PhD
Spain2 sites, 2 recruiting
- Recruiting
Hospital del Mar
Barcelona, Catalonia, 08003
Benedetto Ielpo, PhD
Benedetto Ielpo, PhD
- Not yet recruiting
University of Navarrra Hospital (Clinica Universitaria)
Pamplona, Navarre, 31008
Fernando Rotellar, PhD
Fernando Rotellar, PhD
France1 site, 1 recruiting
- Not yet recruiting
Antoine-Béclère Hospital
Paris, Île-de-France Region, 92140
Ibrahim Dagher, PhD
Ibrahim Dagher, PhD
Germany1 site, 1 recruiting
- Recruiting
Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
Saarbrücken, Saarland, 66119
Gregor Stavrou, MD
Gregor Stavrou, MD
Luxembourg1 site, 1 recruiting
- Recruiting
Centre Hospitalier du Luxembourg
Luxembourg, L-1210
Edoardo Rosso, MD
Edoardo Rosso, MD
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Østlandet, N-0424
Bjørn Edwin, PhD
Bjørn Edwin, PhD
Russia1 site, 1 recruiting
- Recruiting
Moscow Clinical Scientific Center
Moscow, Moscow Oblast, 111123
Mikhail Efanov, PhD
Mikhail Efanov, PhD
About this study
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.
- Being tested
- Minimally invasive simultaneous resection, Minimally invasive two-stage resection
- Medical subject headings
- Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive simultaneous resectionProcedure or surgery
Also called 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 resectionProcedure or surgery
Also called Minimally invasive sequential resection
Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive two-stage resection | Active comparator | 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. Receives: Procedure: Minimally invasive two-stage resection |
| Minimally invasive simultaneous resection | Experimental | Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure. Receives: Procedure: Minimally invasive simultaneous resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to functional recovery
A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met.
Measured: Expected average of 4 to 12 days postoperatively
Secondary outcomes (15)
R0 resection margin
Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.
Measured: 30 days postoperatively
Length of hospital stay
The length of hospital stay for the surgical procedure(s)
Measured: 30 days postoperatively
Activity tracking using Fitbit™
A patient's functional recovery will also be assessed using the Fitbit smartwatch.
Measured: 14 days pre-operatively and 60 days postoperatively
Intraoperative blood loss
Intraoperative blood loss in milliliters
Measured: During the surgical procedure
Operative time
Operative time in minutes
Measured: Operative time from incision until last suture
Morbidity
Morbidity related to the surgical procedure(s)
Measured: 90-days postoperatively
Postoperative bile leakage
Bile leakage occurring after the liver resection
Measured: 90-days postoperatively
Postoperative anastomotic leakage
Anastomotic leakage occurring after the colorectal resection
Measured: 90-days postoperatively
Conversion to open surgery
Intra-operative conversion to an open or hand-assisted procedure
Measured: During the surgical procedure
Readmission rate
Proportion of patients who is unexpectedly readmitted after the surgical procedure(s)
Measured: 90-days postoperatively
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.
Measured: 1 year postoperatively
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.
Measured: 30 days postoperatively
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.
Measured: 1 year postoperatively
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.
Measured: 5 years postoperatively
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.
Measured: 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start6 Aug 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal Neoplasms MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Professor Mohammed Abu Hilal, MD PhD, Study chair, Fondazione Poliambulanza Istituto Ospedaliero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138094
- Sponsor's protocol ID
- NP3969
- Acronym
- LIVACOR
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30069639Pan 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.
PubMed 32958079Boudjema 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.
PubMed 32209911Gavriilidis 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.
PubMed 28888775
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
- ClinicalTrials.gov ID
- NCT05138094
- Acronym / sponsor ID
- LIVACOR / NP3969
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- 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
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive two-stage resection | Active comparator | Procedure: Minimally invasive two-stage resectionMinimally 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 simultaneous resection | Experimental | Procedure: Minimally invasive simultaneous resectionMinimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive simultaneous resectionAlso: Minimally invasive combined resection, Minimally invasive synchronous resectionOne minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed. | Procedure or surgery | Minimally invasive simultaneous resection |
| Minimally invasive two-stage resectionAlso: Minimally invasive sequential resectionTwo minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed | Procedure or surgery | Minimally invasive two-stage resection |
Primary outcome
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.
15 secondary outcomes
R0 resection margin
Time frame: 30 days postoperatively
Length of hospital stay
Time frame: 30 days postoperatively
Activity tracking using Fitbit™
Time frame: 14 days pre-operatively and 60 days postoperatively
Intraoperative blood loss
Time frame: During the surgical procedure
Operative time
Time frame: Operative time from incision until last suture
Morbidity
Time frame: 90-days postoperatively
Postoperative bile leakage
Time frame: 90-days postoperatively
Postoperative anastomotic leakage
Time frame: 90-days postoperatively
Conversion to open surgery
Time frame: During the surgical procedure
Readmission rate
Time frame: 90-days postoperatively
Health-Related Quality of Life
Time frame: 1 year postoperatively
Reasons for delay of discharge after functional recovery
Time frame: 30 days postoperatively
Hospital and societal costs
Time frame: 1 year postoperatively
Three and five-year recurrence free survival
Time frame: 5 years postoperatively
Three and five-year overall survival
Time frame: 5 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Background: PubMed 30069639van 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.
- Background: PubMed 32958079Pan 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.
- Background: PubMed 32209911Boudjema 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.
- Background: PubMed 28888775Gavriilidis 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.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Neoplasms Malignant
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Mohammed Abu Hilal, MD PhD contact
Professor Mohammed Abu Hilal, MD PhD study chair
Fondazione Poliambulanza Istituto Ospedaliero
28 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive simultaneous resection and Minimally invasive two-stage resection in people with Colorectal Neoplasms Malignant and Neoplasm Metastasis, run by Fondazione Poliambulanza Istituto Ospedaliero at 28 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, United Kingdom, Belgium, Netherlands, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasper Sijberden, MD (0031630150451, jasper.sijberden@poliambulanza.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to functional recovery (time frame: Expected average of 4 to 12 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138094, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.