Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study (Oslo-CoMet)

January 4, 2017 updated by: Åsmund Avdem Fretland, Oslo University Hospital

Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases

The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. The study will include all non-anatomic liver resections in our institution.

The primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. Secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Full protocol is published open access in Trialsjournal:

http://www.trialsjournal.com/content/16/1/73

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients eligible for radical liver resection without formal liver resection or without assistance of radiofrequency ablation

Exclusion Criteria:

  • Inability to give written informed concent
  • Patients with tumors that can't be resected without reconstruction of vessels or bile ducts
  • Patients with tumors that can't be resected without 1)formal liver resection 2)combination with radiofrequency ablation
  • Patients with extrahepatic metastasis except resectable metastasis in lungs and adrenals
  • Pre- and peroperative diagnosis of non radically treatable disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Open liver resection
Patients will be operated with open liver resection
Procedure: Open liver resection
Patients will be operated with open liver resection for colorectal metastasis
Other Names:
  • Ultrasound
  • Open liver resection using standard technique:
  • Ligasure
  • CUSA
  • Thunderbeat
  • Autosonix
  • SonoSurg
ACTIVE_COMPARATOR: Laparoscopic liver resection
Patients will be operated with laparoscopic liver resection
Procedure: Laparoscopic liver resection
Patients will be operated with laparoscopic liver resection
Other Names:
  • Ligasure
  • CUSA
  • Thunderbeat
  • Autosonix
  • SonoSurg
  • Laparoscopic liver resection using standardized technique:
  • Laparoscopic ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative morbidity
Time Frame: Within 30 days after surgery
This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity within the first 30 days is the primary outcome (morbidity, yes/no), and will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al, by the Accordion system and by the Comprehensive Complication Index
Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 year survival
Time Frame: 5 years after surgery

5 year survival

  • overall
  • disease free
  • recurrence free
5 years after surgery
Recurrence pattern
Time Frame: 5 years
Pattern of recurrence in liver and extrahepatic. Studied by postoperative CT every 4 months for 2 years and every 6 months for the following 3 years. Local recurrence and new tumors will be recorded.
5 years
Immediate oncologic outcome
Time Frame: 2 months after surgery
Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.
2 months after surgery
Postoperative quality of life
Time Frame: Up to 2 years
Evaluation of postoperative quality of life at baseline, 1 month, 4 months and 2 years using the SF-36 and the EORTC qlq-30 lmc-21 forms
Up to 2 years
Surgical trauma and activation of the immune system
Time Frame: 72 hours
Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points.
72 hours
Health economy
Time Frame: 1 year
We intend to compare overall cost of treatment for the hospital and for the health care system
1 year
Severity of postoperative pain
Time Frame: 4 months
To compare pain the first 5 postoperative days, at 1 month and 4 months. Patients in the open group will be randomized to receiving either a patient controlled analgesic pump containing opioids, or a patient controlled epidural analgesic pump. In laparoscopic group all patients will receive a PCA.
4 months
Molecular biology
Time Frame: 20 years
The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points.
20 years
Anti-tumor immunology
Time Frame: 20 years
The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors
20 years
Imaging
Time Frame: 5 years
The aim is to evaluate two new imaging methods, CT perfusion of liver and LIME-PET, in order to optimize the preoperative identification of colorectal liver metastases.
5 years
Severity of morbidity
Time Frame: 30 days
Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system
30 days
Level of adhesions
Time Frame: 2 years
Level of adhesions will be recorded during repeated liver resection in patients formerly randomized to open or laparoscopic liver resection. a modified version of the peritoneal adhesion index will be used for scoring.
2 years
Number of patients that complete adjuvant oncologic treatment
Time Frame: 1 year
Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups.
1 year
Readmissions
Time Frame: 30 days
Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.
30 days
Incidence of incisional hernia
Time Frame: 1 year
CT scans will be performed to examine for incisional hernia 1 year after surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Helse Sor-Ost

Investigators

  • Study Chair: Bjørn Edwin, MD, PhD, Oslo University Hospital - The Interventional Centre
  • Principal Investigator: Bjorn Edwin, MD, PhD, Oslo University Hospital - The Interventional Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (ESTIMATE)

January 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1285/REK sør-øst B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Not decided yet but results will be public no matter the outcome of the trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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