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

Primary Purpose

Secondary Malignant Neoplasm of Liver, Colorectal Neoplasms

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Open liver resection
Laparoscopic liver resection
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Malignant Neoplasm of Liver focused on measuring Open liver resection, Laparoscopic liver resection, Colorectal cancer liver metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open liver resection

Laparoscopic liver resection

Arm Description

Patients will be operated with open liver resection

Patients will be operated with laparoscopic liver resection

Outcomes

Primary Outcome Measures

Perioperative morbidity
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

Secondary Outcome Measures

5 year survival
5 year survival overall disease free recurrence free
Recurrence pattern
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.
Immediate oncologic outcome
Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.
Postoperative quality of life
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
Surgical trauma and activation of the immune system
Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points.
Health economy
We intend to compare overall cost of treatment for the hospital and for the health care system
Severity of postoperative pain
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.
Molecular biology
The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points.
Anti-tumor immunology
The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors
Imaging
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.
Severity of morbidity
Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system
Level of adhesions
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.
Number of patients that complete adjuvant oncologic treatment
Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups.
Readmissions
Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.
Incidence of incisional hernia
CT scans will be performed to examine for incisional hernia 1 year after surgery

Full Information

First Posted
January 13, 2012
Last Updated
January 4, 2017
Sponsor
Oslo University Hospital
Collaborators
Helse Sor-Ost
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1. Study Identification

Unique Protocol Identification Number
NCT01516710
Brief Title
Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study
Acronym
Oslo-CoMet
Official Title
Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Helse Sor-Ost

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Full protocol is published open access in Trialsjournal: http://www.trialsjournal.com/content/16/1/73

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Malignant Neoplasm of Liver, Colorectal Neoplasms
Keywords
Open liver resection, Laparoscopic liver resection, Colorectal cancer liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open liver resection
Arm Type
Active Comparator
Arm Description
Patients will be operated with open liver resection
Arm Title
Laparoscopic liver resection
Arm Type
Active Comparator
Arm Description
Patients will be operated with laparoscopic liver resection
Intervention Type
Procedure
Intervention Name(s)
Open liver resection
Other Intervention Name(s)
Open liver resection using standard technique:, Ligasure, CUSA, Thunderbeat, Autosonix, SonoSurg, Ultrasound
Intervention Description
Patients will be operated with open liver resection for colorectal metastasis
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic liver resection
Other Intervention Name(s)
Laparoscopic liver resection using standardized technique:, Ligasure, CUSA, Thunderbeat, Autosonix, SonoSurg, Laparoscopic ultrasound
Intervention Description
Patients will be operated with laparoscopic liver resection
Primary Outcome Measure Information:
Title
Perioperative morbidity
Description
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
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
5 year survival
Description
5 year survival overall disease free recurrence free
Time Frame
5 years after surgery
Title
Recurrence pattern
Description
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.
Time Frame
5 years
Title
Immediate oncologic outcome
Description
Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.
Time Frame
2 months after surgery
Title
Postoperative quality of life
Description
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
Time Frame
Up to 2 years
Title
Surgical trauma and activation of the immune system
Description
Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points.
Time Frame
72 hours
Title
Health economy
Description
We intend to compare overall cost of treatment for the hospital and for the health care system
Time Frame
1 year
Title
Severity of postoperative pain
Description
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.
Time Frame
4 months
Title
Molecular biology
Description
The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points.
Time Frame
20 years
Title
Anti-tumor immunology
Description
The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors
Time Frame
20 years
Title
Imaging
Description
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.
Time Frame
5 years
Title
Severity of morbidity
Description
Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system
Time Frame
30 days
Title
Level of adhesions
Description
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.
Time Frame
2 years
Title
Number of patients that complete adjuvant oncologic treatment
Description
Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups.
Time Frame
1 year
Title
Readmissions
Description
Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.
Time Frame
30 days
Title
Incidence of incisional hernia
Description
CT scans will be performed to examine for incisional hernia 1 year after surgery
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Edwin, MD, PhD
Organizational Affiliation
Oslo University Hospital - The Interventional Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bjorn Edwin, MD, PhD
Organizational Affiliation
Oslo University Hospital - The Interventional Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Not decided yet but results will be public no matter the outcome of the trial
Citations:
PubMed Identifier
33197213
Citation
Aghayan DL, Kazaryan AM, Dagenborg VJ, Rosok BI, Fagerland MW, Waaler Bjornelv GM, Kristiansen R, Flatmark K, Fretland AA, Edwin B; OSLO-COMET Survival Study Collaborators. Long-Term Oncologic Outcomes After Laparoscopic Versus Open Resection for Colorectal Liver Metastases : A Randomized Trial. Ann Intern Med. 2021 Feb;174(2):175-182. doi: 10.7326/M20-4011. Epub 2020 Nov 17.
Results Reference
derived
PubMed Identifier
31322735
Citation
Fretland AA, Dagenborg VJ, Waaler Bjornelv GM, Aghayan DL, Kazaryan AM, Barkhatov L, Kristiansen R, Fagerland MW, Edwin B, Andersen MH. Quality of life from a randomized trial of laparoscopic or open liver resection for colorectal liver metastases. Br J Surg. 2019 Sep;106(10):1372-1380. doi: 10.1002/bjs.11227. Epub 2019 Jul 19.
Results Reference
derived
PubMed Identifier
25872027
Citation
Fretland AA, Kazaryan AM, Bjornbeth BA, Flatmark K, Andersen MH, Tonnessen TI, Bjornelv GM, Fagerland MW, Kristiansen R, Oyri K, Edwin B. Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial. Trials. 2015 Mar 4;16:73. doi: 10.1186/s13063-015-0577-5.
Results Reference
derived

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Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

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