Simultaneous Resection of Colorectal Cancer With Synchronous Liver Metastases (RESECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02954913|
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : February 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|ColoRectal Cancer Liver Metastases Liver Metastasis Colon Cancer Surgery Complication||Procedure: Simultaneous Resection||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Simultaneous RESEction of Colorectal Cancer With Synchronous Liver MeTastases (RESECT): A Feasibility Study|
|Actual Study Start Date :||February 14, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Simultaneous Resection
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.
Procedure: Simultaneous 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.
- 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)
- Perioperative Mortality [ Time Frame: 90 days from the Index Operation ]188.8.131.52. 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.
- Accrual Rate [ Time Frame: 12 months from the study's start date ]184.108.40.206. 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.
- Global Health-Related Quality of Life [ Time Frame: Baseline to 3 months following index surgery ]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.
- Cost Analysis [ Time Frame: 90 days from the Index Operation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954913
|Contact: Pablo E Serrano Aybar, MD, MPH, MSc, FACS||905-521-2100 ext firstname.lastname@example.org|
|Contact: Marlie G Valencia, BHSc||905-521-2100 ext email@example.com|
|Juravinski Hospital and Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada, L8V1C3|
|Contact: Pablo E Serrano, MD 905-521-2100 ext 43872 firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Paul Karanicolas, MD 416-480-4774 email@example.com|
|Principal Investigator: Paul Karanicolas, MD|
|Sub-Investigator: Julie Hallet, MD|
|Principal Investigator:||Pablo E Serrano Aybar, MD, MPH, MSc, FACS||Hamilton Health Sciences Corporation|