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

This study is currently recruiting participants.
Verified January 2013 by Oslo University Hospital
Sponsor:
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01516710
First received: January 13, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Secondary Malignant Neoplasm of Liver
Colorectal Neoplasms
 Procedure: Open liver resection
Procedure: Laparoscopic liver resection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Perioperative morbidity [ Time Frame: Within 4 months after surgery ] [ Designated as safety issue: Yes ]
    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 will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al.


Secondary Outcome Measures:
  • 5 year survival [ Time Frame: 5 years after surgery ] [ Designated as safety issue: No ]

    5 year survival

    • overall
    • disease free
    • recurrence free

  • Recurrence pattern [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Pattern of recurrence in liver and extrahepatic.

  • Immediate oncologic outcome [ Time Frame: 2 months after surgery ] [ Designated as safety issue: No ]
    Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.

  • Postoperative quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation of postoperative quality of life at baseline, 1 month and 6 months

  • Surgical trauma and activation of the immune system [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We intend to compare overall cost of treatment for the hospital and for the health care system

  • Postoperative pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    To compare pain on the 2. postoperative day and after 1 month.

  • Molecular biology [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors

  • Imaging [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 340
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Open liver resection using standard technique:
  • Ligasure
  • CUSA
  • Thunderbeat
  • Autosonix
  • SonoSurg
  • Ultrasound
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:
  • Laparoscopic liver resection using standardized technique:
  • Ligasure
  • CUSA
  • Thunderbeat
  • Autosonix
  • SonoSurg
  • Laparoscopic ultrasound

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Peroperative diagnosis of non radically treatable disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516710

Contacts
Contact: Bjørn Edwin, MD, PhD +4723070000 bjoedw@ous-hf.no
Contact: Åsmund A Fretland, MD +4723070000 aafret@ous-hf.no

Locations
Norway
Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital Recruiting
Oslo, Norway, 0424
Contact: Marianne Moe, Head nurse     +4723072529        
Sponsors and Collaborators
Oslo University Hospital
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
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01516710     History of Changes
Other Study ID Numbers: 2011/1285/REK sør-øst B
Study First Received: January 13, 2012
Last Updated: January 2, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Open liver resection
Laparoscopic liver resection
Colorectal cancer liver metastases

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

ClinicalTrials.gov processed this record on May 22, 2013