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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| University Hospital Southampton NHS Foundation Trust | OTHER |
| University Hospital Birmingham NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Minimally invasive simultaneous resection | Experimental | Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive simultaneous resection | Procedure | One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to functional recovery | A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met. | Expected average of 4 to 12 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection margin | Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed. | 30 days postoperatively |
| Length of hospital stay |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasper Sijberden, MD | Contact | 0031630150451 | jasper.sijberden@poliambulanza.it | |
| Professor Mohammed Abu Hilal, MD PhD | Contact | abuhilal9@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Professor Mohammed Abu Hilal, MD PhD | Fondazione Poliambulanza Istituto Ospedaliero | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Not yet recruiting | Genk | Limburg | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30069639 | Background | 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. | |
| 32958079 |
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| Liverpool University Hospitals NHS Foundation Trust | OTHER_GOV |
| King's College Hospital NHS Trust | OTHER |
| Manchester University NHS Foundation Trust | OTHER_GOV |
| 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_GOV |
| 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 |
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|
| Minimally invasive two-stage resection | Procedure | Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed |
|
|
The length of hospital stay for the surgical procedure(s)
| 30 days postoperatively |
| Activity tracking using Fitbit™ | A patient's functional recovery will also be assessed using the Fitbit smartwatch. | 14 days pre-operatively and 60 days postoperatively |
| Intraoperative blood loss | Intraoperative blood loss in milliliters | During the surgical procedure |
| Operative time | Operative time in minutes | Operative time from incision until last suture |
| Morbidity | Morbidity related to the surgical procedure(s) | 90-days postoperatively |
| Postoperative bile leakage | Bile leakage occurring after the liver resection | 90-days postoperatively |
| Postoperative anastomotic leakage | Anastomotic leakage occurring after the colorectal resection | 90-days postoperatively |
| Conversion to open surgery | Intra-operative conversion to an open or hand-assisted procedure | During the surgical procedure |
| Readmission rate | Proportion of patients who is unexpectedly readmitted after the surgical procedure(s) | 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. | 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. | 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. | 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. | 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. | 5 years postoperatively |
| General Hospital Groeninge | Recruiting | Kortrijk | West Flanders | 8500 | Belgium |
|
| Antoine-Béclère Hospital | Not yet recruiting | Paris | Île-de-France Region | 92140 | France |
|
| Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie | Recruiting | Saarbrücken | Saarland | 66119 | Germany |
|
| Federico II University Hospital | Not yet recruiting | Naples | Calabria | 80131 | Italy |
|
| Azienda USL di Bologna | Recruiting | Bologna | Emilia-Romagna | 40124 | Italy |
|
| Azienda Ospedaliero-Universitaria di Modena | Not yet recruiting | Modena | Emilia-Romagna | 41125 | Italy |
|
| Parma University Hospital | Not yet recruiting | Parma | Emilia-Romagna | 43126 | Italy |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Lazio | 00168 | Italy |
|
| Fondazione Poliambulanza Istituto Ospedaliero | Recruiting | Brescia | Lombardy | 25124 | Italy |
|
| San Raffaele University Hospital | Not yet recruiting | Milan | Lombardy | 20132 | Italy |
|
| Mauriziano Umberto I Hospital | Not yet recruiting | Turin | Piedmont | 10128 | Italy |
|
| Ospedali Riuniti | Not yet recruiting | Ancona | The Marches | 60126 | Italy |
|
| University Hospital Padova | Recruiting | Padova | Veneto | 35128 | Italy |
|
| Centre Hospitalier du Luxembourg | Recruiting | Luxembourg | L-1210 | Luxembourg |
|
| Maastricht University Medical Center | Not yet recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
|
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
|
| Oslo University Hospital | Recruiting | Oslo | Østlandet | N-0424 | Norway |
|
| Moscow Clinical Scientific Center | Recruiting | Moscow | Moscow Oblast | 111123 | Russia |
|
| Hospital del Mar | Recruiting | Barcelona | Catalonia | 08003 | Spain |
|
| University of Navarrra Hospital (Clinica Universitaria) | Not yet recruiting | Pamplona | Navarre | 31008 | Spain |
|
| Manchester University NHS Foundation Trust | Not yet recruiting | Manchester | North West England | M13 9WL | United Kingdom |
|
| Newcastle-upon-Tyne Hospitals NHS Trust | Not yet recruiting | Newcastle | Northeast England | NE1 4LP | United Kingdom |
|
| Liverpool University Hospitals NHS Foundation Trust | Not yet recruiting | Liverpool | Northwest England | L7 8XP | United Kingdom |
|
| University Hospital Southampton NHS Foundation Trust | Not yet recruiting | Southampton | South East England | SO16 6YD | United Kingdom |
|
| King's College Hospital NHS Trust | Not yet recruiting | London | Southeast England | SE5 9RS | United Kingdom |
|
| University Hospital Plymouth NHS Trust | Not yet recruiting | Plymouth | Southwest England | PL6 8DH | United Kingdom |
|
| University Hospital Birmingham NHS Foundation Trust | Not yet recruiting | Birmingham | West Midlands | B15 1NT | United Kingdom |
|
| 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. |
| 32209911 | Background | 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. |
| 28888775 | Background | 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. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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