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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 6, 2014
Last verified: October 2014

January 13, 2012
October 6, 2014
January 2012
December 2015   (final data collection date for primary outcome measure)
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, by the Accordion system and by the Comprehensive Complication Index
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.
Complete list of historical versions of study NCT01516710 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 evalutation, 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 perioperatiev 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 helath 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.
Not Provided
Not Provided
 
Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Secondary Malignant Neoplasm of Liver
  • Colorectal Neoplasms
  • 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
  • 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
  • Active Comparator: Open liver resection
    Patients will be operated with open liver resection
    Intervention: Procedure: Open liver resection
  • Active Comparator: Laparoscopic liver resection
    Patients will be operated with laparoscopic liver resection
    Intervention: Procedure: Laparoscopic liver resection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
280
December 2025
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bjørn Edwin, MD, PhD +4723070000 bjoedw@ous-hf.no
Contact: Åsmund A Fretland, MD +4723070000 aafret@ous-hf.no
Norway
 
NCT01516710
2011/1285/REK sør-øst B
No
Oslo University Hospital
Oslo University Hospital
Helse Sor-Ost
Study Chair: Bjørn Edwin, MD, PhD Oslo University Hospital - The Interventional Centre
Principal Investigator: Bjorn Edwin, MD, PhD Oslo University Hospital - The Interventional Centre
Oslo University Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP