ColoRectal CancerRESECTNCT02954913
Simultaneous Resection of Colorectal Cancer With Synchronous Liver Metastases
A study testing Simultaneous Resection in people with ColoRectal Cancer and Liver Metastases, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
Synchronous colorectal cancer with liver metastases, defined as the diagnosis of a primary colorectal tumour and liver metastases within 12 months, is a common problem faced by colorectal and hepatobiliary surgeons.(Adam) The "traditional approach" is to perform staged resections unless the liver resection required is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ColoRectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer
- What is being tested?
- Simultaneous Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesCanada
- Study dates
- 14 Feb 2017to 9 Feb 2021
- 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
- Patients who present with resectable synchronous colorectal adenocarcinoma and liver metastases.
- Patients who have a planned resection of their colorectal adenocarcinoma and liver metastases.
- Patients who are able to provide informed consent.
- Note: The primary tumour or the liver metastases may require neoadjuvant therapy to become resectable. Patients with the following histology are eligible for the study: adenocarcinoma, adenosquamous carcinoma, mixed adenocarcinoma-neuroendocrine tumour (adenocarcinoma with neuroendocrine differentiation). Patients with suspicious colorectal mass with probably liver metastases in which pathology only shows high grade dysplasia are also eligible as long as a liver resection is contemplated as part of the operative plan.
Who cannot join
- Extrahepatic disease other than lung.
- Tumours treated with local transanal excision (patients undergoing transanal total mesorectal excision are eligible).
- Patients who require a two stage liver resection, prior liver resection.
- Pregnant or lactating female
- Absolute contraindications for general anesthesia
- Patients who require a complex multi-organ pelvic resection, i.e. pelvic exenteration: including bladder, female or male reproductive organs; patients who only require resection of another pelvic organ (including bladder or female reproductive organs or prostate and seminal vesicles) are eligible.
- Patients undergoing urgent resection of the primary tumour due to bleeding or obstruction in which a simultaneous liver resection is not planned are not eligible for the study, patients who undergo diverting stoma (loop ileostomy or colostomy) prior to resection are eligible.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, L8V1C3
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Simultaneous RESEction of Colorectal Cancer With Synchronous Liver MeTastases (RESECT): A Feasibility Study
Synchronous colorectal cancer with liver metastases, defined as the diagnosis of a primary colorectal tumour and liver metastases within 12 months, is a common problem faced by colorectal and hepatobiliary surgeons.(Adam) The "traditional approach" is to perform staged resections unless the liver resection required is limited (i.e. small wedges of peripheral lesions). The downside of performing staged vs. simultaneous resections is that patients must undergo two major operations instead of one, which limits a patient's ability to return to their pre-surgical state of health in a timely fashion, increasing health care costs (Ejaz) and delaying the start of adjuvant chemotherapy. The disadvantages of a simultaneous approach include longer operating room times potentially increasing the major postoperative complication rate including blood transfusions, surgical site infections, anastomotic leaks and post-hepatectomy liver failure. Recent data from tertiary cancer centres suggest that simultaneous resection of the colon and rectum along with liver resection of any magnitude is feasible and safe.(Silberhumer) Although encouraging, this data comes from specific patients from a highly selected institution, results that are perhaps not generalizable.
This proposal is a feasibility study consisting of a pilot single arm prospective study at two different large-volume Hepatobiliary Centres of patients with synchronous colorectal cancer with liver metastases undergoing simultaneous resection of the colon or rectum and liver to evaluate their complication rates (including the calculation of the comprehensive complication index), quality of life, cost evaluation, and proportion of eligible patients recruited over a 12-month period. The results of this pilot study will provide us with the information necessary to build a large multicentre randomized controlled trial comparing staged vs. simultaneous resection for synchronous colorectal cancer liver metastases.
Read the detailed description
Approximately 30% of patients with colorectal cancer and liver metastases present with synchronous disease.(Manfredi) Resection of colorectal cancer metastases confined to the liver has been shown to offer long-term survival.(Norlinger; Robertson; Nordlinger) However, the optimal timing of surgical resection of synchronous liver metastases in relation to the primary tumour is not well defined. Prior retrospective cohorts and meta-analyses suggest that the simultaneous approach carries similar postoperative complication and perioperative mortality rates.(Slesser; Yin; Martin; Chua; Feng; Reddy; Jarnagin; Capussotti) Most of these reports however, carry a significant selection bias, as surgeons tend to combine limited liver resections and "straightforward" colorectal resections as opposed to complex resections. Recent studies suggest that the postoperative complication risk is similar even in the case of complex liver resections as well as complex colon resections and rectal cancer resections.(Silberhumer; Vigano) Rectal resections when compared to colon resections are thought to be more complex, due to: a higher risk of anastomotic leakage,(Rullier) the use of specific surgical procedures, such as total mesorectal excision (Heald, MacFarlane) and laparoscopic surgery(Bonjer) and the involvement of a multidisciplinary team to determine the use and timing of neoadjuvant chemoradiotherapy.(Jeong; Kapiteijn) The conclusion of these studies was that further data from prospective randomized studies is needed in order to determine whether simultaneous resection is efficient and safe. Improvements in anesthesia, critical care and surgical resection techniques for both liver and colorectal surgery have enabled innovative surgeons and institutions to perform simultaneous resections in complex liver and colorectal cases in a safe manner, and the simultaneous approach has been adopted by many surgeons despite the lack of studies with rigorous methodology to provide good quality data.
Simultaneous colorectal and liver resection has the potential advantage to decrease the total number of complications following surgery, avoiding a second operation thereby improving patient's quality of life, decreasing overall health care costs and avoiding delays in the administration of postoperative chemotherapy. Although the total number of complications can be reduced by performing a single operation, the operating room time is higher which could lead to a higher proportion of major postoperative complications due to hypothermia, prolonged hypovolemia and higher blood loss.
The decision to perform simultaneous resection varies greatly between surgeons and institutions, with some institutions mostly performing simultaneous resections, to others that only perform staged resection and others that perform a combination of staged and simultaneous resections depending on patients' and tumour characteristics, usually performing larger and more complex resections in a staged approach. There is certainly no standard approach to this problem and it continues to be a topic of debate amongst surgeons, medical oncologists and radiation oncologists.
The investigators propose to undertake a feasibility study, including a prospective single arm trial of patients with synchronous colorectal cancer and liver metastases undergoing simultaneous resection to provide us with important information to prepare a large randomized controlled study of simultaneous vs. staged resection. This feasibility study will provide valuable data on the type and proportion of postoperative complications at 90 days following surgery as measured by the comprehensive complication index(Slankamenac 2013) which will help us better understand the postoperative complication rate of the simultaneous approach and also calculate a sample size for a randomized controlled trial based on this primary outcome. This study will also help define the population that should be included in such a trial (all liver resections vs. only major liver resections, etc.). Set criteria for success of this feasibility study will be clearly stated in this proposal in order to determine if it is possible and ethical to move forward with a larger trial. The results of this study could lead to changes in surgical practice by introducing an innovative approach to treat this disease, in a way that could improve patient's quality of life by decreasing postoperative complications and the number of surgical procedures and at the same time lead to cost savings to the health care system.
- Being tested
- Simultaneous Resection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous ResectionProcedure or surgery
Also called Synchronous Colorectal and Liver Resections, Simultaneous Colorectal and Liver Resections, Synchronous Resection
Resections of 3 or more segments of the liver will be considered a major liver resection.(Reddy) The anesthetic technique and the order of liver resection or rectal resection will be determined by each surgeon's standards. It is recommended that a low central venous pressure be maintained in order to decrease intraoperative blood loss (Chen; Hughes) and that liver resection be performed prior to colorectal resection in order to keep a low central venous pressure during that part of the case.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous Resection | Experimental | Patients will undergo resection of the colon or rectum and liver in the same anesthetic setting. The type of colorectal and liver resection will be decided by the treating physician. The type of liver resection will be described according to the Couinaud classification and the Brisbane terminology of liver anatomy. Receives: Procedure: Simultaneous Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index
Postoperative complications used to calculate the Comprehensive Complication Index will be recorded during and following each patient's hospital stay up to 90 days from the index operation and classified according to Clavien-Dindo.(Slankamenac 2013; Dindo; Slankamenac 2014)
Measured: 90 days from the Index Operation
Secondary outcomes (4)
Perioperative Mortality
3.10.2.1. The proportion with its 95% CI of patients who die at 90 days or during the hospital stay for the index operation (perioperative mortality) will be calculated.
Measured: 90 days from the Index Operation
Accrual Rate
3.10.2.2. The proportion of eligible patients enrolled in the study over a 12-month period and the proportion of patients who complete the colorectal resection will be assessed.
Measured: 12 months from the study's start date
Global Health-Related Quality of Life
QoL will be measured using the EORTC-QLQ-C30 (Aaronson; Groenvold) instrument and will be administered at baseline, at 1 and 3 months following surgery.
Measured: Baseline to 3 months following index surgery
Cost Analysis
Health Resource Utilization forms will be used at each patient assessment to determine the number of health related hospital, emergency department or clinic visits, physician appointments and imaging performed. A costing model will be performed by including all factors that drive cost in this patient population.
Measured: 90 days from the Index Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start14 Feb 2017
- Primary completion5 Mar 2020
- Study completion9 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for ColoRectal CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Serrano, Hamilton Health Sciences Corporation
- Investigators
- Pablo E Serrano Aybar, MD, MPH, MSc, FACS, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954913
- Sponsor's protocol ID
- RESECT
- Acronym
- RESECT
- Status last verified
- Feb 2021
- First submitted
- 2 Nov 2016
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adam R, de Gramont A, Figueras J, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Teh C, Tejpar S, Van Cutsem E, Vauthey JN, Pahlman L; of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. Managing synchronous liver metastases from colorectal cancer: a multidisciplinary international consensus. Cancer Treat Rev. 2015 Nov;41(9):729-41. doi: 10.1016/j.ctrv.2015.06.006. Epub 2015 Jun 30.
PubMed 26417845Ejaz A, Semenov E, Spolverato G, Kim Y, Tanner D, Hundt J, Pawlik TM. Synchronous primary colorectal and liver metastasis: impact of operative approach on clinical outcomes and hospital charges. HPB (Oxford). 2014 Dec;16(12):1117-26. doi: 10.1111/hpb.12302. Epub 2014 Jun 26.
PubMed 24965845Silberhumer GR, Paty PB, Temple LK, Araujo RL, Denton B, Gonen M, Nash GM, Allen PJ, DeMatteo RP, Guillem J, Weiser MR, D'Angelica MI, Jarnagin WR, Wong DW, Fong Y. Simultaneous resection for rectal cancer with synchronous liver metastasis is a safe procedure. Am J Surg. 2015 Jun;209(6):935-42. doi: 10.1016/j.amjsurg.2014.09.024. Epub 2014 Dec 13.
PubMed 25601556Manfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9. doi: 10.1097/01.sla.0000217629.94941.cf.
PubMed 16858188Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.
PubMed 24120480Robertson DJ, Stukel TA, Gottlieb DJ, Sutherland JM, Fisher ES. Survival after hepatic resection of colorectal cancer metastases: a national experience. Cancer. 2009 Feb 15;115(4):752-9. doi: 10.1002/cncr.24081.
PubMed 19130462Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Collette L, Praet M, Bethe U, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. Lancet. 2008 Mar 22;371(9617):1007-16. doi: 10.1016/S0140-6736(08)60455-9.
PubMed 18358928Slesser AA, Simillis C, Goldin R, Brown G, Mudan S, Tekkis PP. A meta-analysis comparing simultaneous versus delayed resections in patients with synchronous colorectal liver metastases. Surg Oncol. 2013 Mar;22(1):36-47. doi: 10.1016/j.suronc.2012.11.002. Epub 2012 Dec 14.
PubMed 23253399Yin Z, Liu C, Chen Y, Bai Y, Shang C, Yin R, Yin D, Wang J. Timing of hepatectomy in resectable synchronous colorectal liver metastases (SCRLM): Simultaneous or delayed? Hepatology. 2013 Jun;57(6):2346-57. doi: 10.1002/hep.26283.
PubMed 23359206Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2. doi: 10.1016/S1072-7515(03)00390-9.
PubMed 12892803Chua HK, Sondenaa K, Tsiotos GG, Larson DR, Wolff BG, Nagorney DM. Concurrent vs. staged colectomy and hepatectomy for primary colorectal cancer with synchronous hepatic metastases. Dis Colon Rectum. 2004 Aug;47(8):1310-6. doi: 10.1007/s10350-004-0586-z.
PubMed 15484344Feng Q, Wei Y, Zhu D, Ye L, Lin Q, Li W, Qin X, Lyu M, Xu J. Timing of hepatectomy for resectable synchronous colorectal liver metastases: for whom simultaneous resection is more suitable--a meta-analysis. PLoS One. 2014 Aug 5;9(8):e104348. doi: 10.1371/journal.pone.0104348. eCollection 2014.
PubMed 25093337Reddy SK, Pawlik TM, Zorzi D, Gleisner AL, Ribero D, Assumpcao L, Barbas AS, Abdalla EK, Choti MA, Vauthey JN, Ludwig KA, Mantyh CR, Morse MA, Clary BM. Simultaneous resections of colorectal cancer and synchronous liver metastases: a multi-institutional analysis. Ann Surg Oncol. 2007 Dec;14(12):3481-91. doi: 10.1245/s10434-007-9522-5. Epub 2007 Sep 1.
PubMed 17805933Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3.
PubMed 12368667Capussotti L, Ferrero A, Vigano L, Ribero D, Lo Tesoriere R, Polastri R. Major liver resections synchronous with colorectal surgery. Ann Surg Oncol. 2007 Jan;14(1):195-201. doi: 10.1245/s10434-006-9055-3.
PubMed 17080238
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous RESEction of Colorectal Cancer With Synchronous Liver MeTastases (RESECT): A Feasibility Study
- ClinicalTrials.gov ID
- NCT02954913
- Acronym / sponsor ID
- RESECT / RESECT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 4 Nov 2016 (estimated)
- 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.
Synchronous colorectal cancer with liver metastases, defined as the diagnosis of a primary colorectal tumour and liver metastases within 12 months, is a common problem faced by colorectal and hepatobiliary surgeons.(Adam) The "traditional approach" is to perform staged resections unless the liver resection required is limited (i.e. small wedges of peripheral lesions). The downside of performing staged vs. simultaneous resections is that patients must undergo two major operations instead of one, which limits a patient's ability to return to their pre-surgical state of health in a timely fashion, increasing health care costs (Ejaz) and delaying the start of adjuvant chemotherapy. The disadvantages of a simultaneous approach include longer operating room times potentially increasing the major postoperative complication rate including blood transfusions, surgical site infections, anastomotic leaks and post-hepatectomy liver failure. Recent data from tertiary cancer centres suggest that simultaneous resection of the colon and rectum along with liver resection of any magnitude is feasible and safe.(Silberhumer) Although encouraging, this data comes from specific patients from a highly selected institution, results that are perhaps not generalizable.
This proposal is a feasibility study consisting of a pilot single arm prospective study at two different large-volume Hepatobiliary Centres of patients with synchronous colorectal cancer with liver metastases undergoing simultaneous resection of the colon or rectum and liver to evaluate their complication rates (including the calculation of the comprehensive complication index), quality of life, cost evaluation, and proportion of eligible patients recruited over a 12-month period. The results of this pilot study will provide us with the information necessary to build a large multicentre randomized controlled trial comparing staged vs. simultaneous resection for synchronous colorectal cancer liver metastases.
Detailed description
Approximately 30% of patients with colorectal cancer and liver metastases present with synchronous disease.(Manfredi) Resection of colorectal cancer metastases confined to the liver has been shown to offer long-term survival.(Norlinger; Robertson; Nordlinger) However, the optimal timing of surgical resection of synchronous liver metastases in relation to the primary tumour is not well defined. Prior retrospective cohorts and meta-analyses suggest that the simultaneous approach carries similar postoperative complication and perioperative mortality rates.(Slesser; Yin; Martin; Chua; Feng; Reddy; Jarnagin; Capussotti) Most of these reports however, carry a significant selection bias, as surgeons tend to combine limited liver resections and "straightforward" colorectal resections as opposed to complex resections. Recent studies suggest that the postoperative complication risk is similar even in the case of complex liver resections as well as complex colon resections and rectal cancer resections.(Silberhumer; Vigano) Rectal resections when compared to colon resections are thought to be more complex, due to: a higher risk of anastomotic leakage,(Rullier) the use of specific surgical procedures, such as total mesorectal excision (Heald, MacFarlane) and laparoscopic surgery(Bonjer) and the involvement of a multidisciplinary team to determine the use and timing of neoadjuvant chemoradiotherapy.(Jeong; Kapiteijn) The conclusion of these studies was that further data from prospective randomized studies is needed in order to determine whether simultaneous resection is efficient and safe. Improvements in anesthesia, critical care and surgical resection techniques for both liver and colorectal surgery have enabled innovative surgeons and institutions to perform simultaneous resections in complex liver and colorectal cases in a safe manner, and the simultaneous approach has been adopted by many surgeons despite the lack of studies with rigorous methodology to provide good quality data.
Simultaneous colorectal and liver resection has the potential advantage to decrease the total number of complications following surgery, avoiding a second operation thereby improving patient's quality of life, decreasing overall health care costs and avoiding delays in the administration of postoperative chemotherapy. Although the total number of complications can be reduced by performing a single operation, the operating room time is higher which could lead to a higher proportion of major postoperative complications due to hypothermia, prolonged hypovolemia and higher blood loss.
The decision to perform simultaneous resection varies greatly between surgeons and institutions, with some institutions mostly performing simultaneous resections, to others that only perform staged resection and others that perform a combination of staged and simultaneous resections depending on patients' and tumour characteristics, usually performing larger and more complex resections in a staged approach. There is certainly no standard approach to this problem and it continues to be a topic of debate amongst surgeons, medical oncologists and radiation oncologists.
The investigators propose to undertake a feasibility study, including a prospective single arm trial of patients with synchronous colorectal cancer and liver metastases undergoing simultaneous resection to provide us with important information to prepare a large randomized controlled study of simultaneous vs. staged resection. This feasibility study will provide valuable data on the type and proportion of postoperative complications at 90 days following surgery as measured by the comprehensive complication index(Slankamenac 2013) which will help us better understand the postoperative complication rate of the simultaneous approach and also calculate a sample size for a randomized controlled trial based on this primary outcome. This study will also help define the population that should be included in such a trial (all liver resections vs. only major liver resections, etc.). Set criteria for success of this feasibility study will be clearly stated in this proposal in order to determine if it is possible and ethical to move forward with a larger trial. The results of this study could lead to changes in surgical practice by introducing an innovative approach to treat this disease, in a way that could improve patient's quality of life by decreasing postoperative complications and the number of surgical procedures and at the same time lead to cost savings to the health care system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Resection | Experimental | Procedure: Simultaneous ResectionPatients will undergo resection of the colon or rectum and liver in the same anesthetic setting. The type of colorectal and liver resection will be decided by the treating physician. The type of liver resection will be described according to the Couinaud classification and the Brisbane terminology of liver anatomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who present with resectable synchronous colorectal adenocarcinoma and liver metastases.
- Patients who have a planned resection of their colorectal adenocarcinoma and liver metastases.
- Patients who are able to provide informed consent.
- Note: The primary tumour or the liver metastases may require neoadjuvant therapy to become resectable. Patients with the following histology are eligible for the study: adenocarcinoma, adenosquamous carcinoma, mixed adenocarcinoma-neuroendocrine tumour (adenocarcinoma with neuroendocrine differentiation). Patients with suspicious colorectal mass with probably liver metastases in which pathology only shows high grade dysplasia are also eligible as long as a liver resection is contemplated as part of the operative plan.
Key exclusion criteria (7 listed)
- Extrahepatic disease other than lung.
- Tumours treated with local transanal excision (patients undergoing transanal total mesorectal excision are eligible).
- Patients who require a two stage liver resection, prior liver resection.
- Pregnant or lactating female
- Absolute contraindications for general anesthesia
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 |
|---|---|---|
| Simultaneous ResectionAlso: Synchronous Colorectal and Liver Resections, Simultaneous Colorectal and Liver Resections, Synchronous ResectionResections of 3 or more segments of the liver will be considered a major liver resection.(Reddy) The anesthetic technique and the order of liver resection or rectal resection will be determined by each surgeon's standards. It is recommended that a low central venous pressure be maintained in order to decrease intraoperative blood loss (Chen; Hughes) and that liver resection be performed prior to colorectal resection in order to keep a low central venous pressure during that part of the case. | Procedure or surgery | Simultaneous Resection |
Primary outcome
Comprehensive Complication Index
Time frame: 90 days from the Index Operation
Postoperative complications used to calculate the Comprehensive Complication Index will be recorded during and following each patient's hospital stay up to 90 days from the index operation and classified according to Clavien-Dindo.(Slankamenac 2013; Dindo; Slankamenac 2014)
4 secondary outcomes
Perioperative Mortality
Time frame: 90 days from the Index Operation
Accrual Rate
Time frame: 12 months from the study's start date
Global Health-Related Quality of Life
Time frame: Baseline to 3 months following index surgery
Cost Analysis
Time frame: 90 days from the Index Operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 26417845Adam R, de Gramont A, Figueras J, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Teh C, Tejpar S, Van Cutsem E, Vauthey JN, Pahlman L; of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. Managing synchronous liver metastases from colorectal cancer: a multidisciplinary international consensus. Cancer Treat Rev. 2015 Nov;41(9):729-41. doi: 10.1016/j.ctrv.2015.06.006. Epub 2015 Jun 30.
- Background: PubMed 24965845Ejaz A, Semenov E, Spolverato G, Kim Y, Tanner D, Hundt J, Pawlik TM. Synchronous primary colorectal and liver metastasis: impact of operative approach on clinical outcomes and hospital charges. HPB (Oxford). 2014 Dec;16(12):1117-26. doi: 10.1111/hpb.12302. Epub 2014 Jun 26.
- Background: PubMed 25601556Silberhumer GR, Paty PB, Temple LK, Araujo RL, Denton B, Gonen M, Nash GM, Allen PJ, DeMatteo RP, Guillem J, Weiser MR, D'Angelica MI, Jarnagin WR, Wong DW, Fong Y. Simultaneous resection for rectal cancer with synchronous liver metastasis is a safe procedure. Am J Surg. 2015 Jun;209(6):935-42. doi: 10.1016/j.amjsurg.2014.09.024. Epub 2014 Dec 13.
- Background: PubMed 16858188Manfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9. doi: 10.1097/01.sla.0000217629.94941.cf.
- Background: PubMed 24120480Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.
- Background: PubMed 19130462Robertson DJ, Stukel TA, Gottlieb DJ, Sutherland JM, Fisher ES. Survival after hepatic resection of colorectal cancer metastases: a national experience. Cancer. 2009 Feb 15;115(4):752-9. doi: 10.1002/cncr.24081.
- Background: PubMed 18358928Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Collette L, Praet M, Bethe U, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. Lancet. 2008 Mar 22;371(9617):1007-16. doi: 10.1016/S0140-6736(08)60455-9.
- Background: PubMed 23253399Slesser AA, Simillis C, Goldin R, Brown G, Mudan S, Tekkis PP. A meta-analysis comparing simultaneous versus delayed resections in patients with synchronous colorectal liver metastases. Surg Oncol. 2013 Mar;22(1):36-47. doi: 10.1016/j.suronc.2012.11.002. Epub 2012 Dec 14.
- Background: PubMed 23359206Yin Z, Liu C, Chen Y, Bai Y, Shang C, Yin R, Yin D, Wang J. Timing of hepatectomy in resectable synchronous colorectal liver metastases (SCRLM): Simultaneous or delayed? Hepatology. 2013 Jun;57(6):2346-57. doi: 10.1002/hep.26283.
- Background: PubMed 12892803Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2. doi: 10.1016/S1072-7515(03)00390-9.
- Background: PubMed 15484344Chua HK, Sondenaa K, Tsiotos GG, Larson DR, Wolff BG, Nagorney DM. Concurrent vs. staged colectomy and hepatectomy for primary colorectal cancer with synchronous hepatic metastases. Dis Colon Rectum. 2004 Aug;47(8):1310-6. doi: 10.1007/s10350-004-0586-z.
- Background: PubMed 25093337Feng Q, Wei Y, Zhu D, Ye L, Lin Q, Li W, Qin X, Lyu M, Xu J. Timing of hepatectomy for resectable synchronous colorectal liver metastases: for whom simultaneous resection is more suitable--a meta-analysis. PLoS One. 2014 Aug 5;9(8):e104348. doi: 10.1371/journal.pone.0104348. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Pablo E Serrano Aybar, MD, MPH, MSc, FACS principal investigator
Hamilton Health Sciences Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Resection in people with ColoRectal Cancer and Liver Metastases, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (time frame: 90 days from the Index Operation). 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 NCT02954913, which also lists 33 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 12 Feb 2021.