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Simultaneous Resection of Colorectal Cancer With Synchronous Liver Metastases (RESECT)

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ClinicalTrials.gov Identifier: NCT02954913
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pablo Serrano, Hamilton Health Sciences Corporation

Brief 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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Synchronous Colorectal and Liver Resections
  • Simultaneous Colorectal and Liver Resections
  • Synchronous Resection




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Perioperative Mortality [ Time Frame: 90 days from the Index Operation ]
    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.

  2. Accrual Rate [ Time Frame: 12 months from the study's start date ]
    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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who present with resectable synchronous colorectal adenocarcinoma and liver metastases.
  2. Patients who have a planned resection of their colorectal adenocarcinoma and liver metastases.
  3. 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.

Exclusion Criteria:

  1. Extrahepatic disease other than lung.
  2. Tumours treated with local transanal excision (patients undergoing transanal total mesorectal excision are eligible).
  3. Patients who require a two stage liver resection, prior liver resection.
  4. Pregnant or lactating female
  5. Absolute contraindications for general anesthesia
  6. 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.
  7. 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Pablo E Serrano Aybar, MD, MPH, MSc, FACS 905-521-2100 ext 43872 serrano@mcmaster.ca
Contact: Marlie G Valencia, BHSc 905-521-2100 ext 43921 valencmg@mcmaster.ca

Locations
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Canada, Ontario
Juravinski Hospital and Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V1C3
Contact: Pablo E Serrano, MD    905-521-2100 ext 43872    serrano@mcmaster.ca   
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Paul Karanicolas, MD    416-480-4774    paul.karanicolas@sunnybrook.ca   
Principal Investigator: Paul Karanicolas, MD         
Sub-Investigator: Julie Hallet, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Pablo E Serrano Aybar, MD, MPH, MSc, FACS Hamilton Health Sciences Corporation

Publications:

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Responsible Party: Pablo Serrano, Hepatobiliary & Pancreatic Surgical Oncologist, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02954913     History of Changes
Other Study ID Numbers: RESECT
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Liver Extracts
Hematinics