Simultaneous Resection of Colorectal Cancer With Synchronous Liver Metastases

NCT02954913 | Completed DMC

• 1 other identifier: RESECT
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

ColoRectal Cancer; Liver Metastases; Liver Metastasis Colon Cancer; Surgery; Complication

Outcome Measures

Primary Outcomes (1)

• 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)

  90 days from the Index Operation

Secondary Outcomes (4)

• Perioperative Mortality

  90 days from the Index Operation

• Accrual Rate

  12 months from the study's start date

• Global Health-Related Quality of Life

  Baseline to 3 months following index surgery

• Cost Analysis

  90 days from the Index Operation

Study Arms (1)

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.

Procedure: Simultaneous Resection

Interventions

Simultaneous Resection PROCEDURE

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.

Also known as: Synchronous Colorectal and Liver Resections, Simultaneous Colorectal and Liver Resections, Synchronous Resection

Simultaneous Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (2)

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V1C3, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (33)

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pablo E Serrano Aybar, MD, MPH, MSc, FACS

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hepatobiliary & Pancreatic Surgical Oncologist

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: February 14, 2017
• Primary Completion: March 5, 2020
• Study Completion: February 9, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)