Try our beta test site

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Åsmund Avdem Fretland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01516710
First received: January 13, 2012
Last updated: January 4, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 5 year survival [ Time Frame: 5 years after surgery ]

    5 year survival

    • overall
    • disease free
    • recurrence free

  • 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.

  • Immediate oncologic outcome [ Time Frame: 2 months after surgery ]
    Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.

  • 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

  • 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.

  • Health economy [ Time Frame: 1 year ]
    We intend to compare overall cost of treatment for the hospital and for the health care system

  • 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.

  • 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.

  • Anti-tumor immunology [ Time Frame: 20 years ]
    The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors

  • 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.

  • Severity of morbidity [ Time Frame: 30 days ]
    Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system

  • 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.

  • 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.

  • Readmissions [ Time Frame: 30 days ]
    Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.

  • Incidence of incisional hernia [ Time Frame: 1 year ]
    CT scans will be performed to examine for incisional hernia 1 year after surgery


Enrollment: 280
Study Start Date: January 2012
Estimated Study Completion Date: December 2025
Primary Completion Date: April 2016 (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

Detailed Description:

Full protocol is published open access in Trialsjournal:

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Pre- and peroperative diagnosis of non radically treatable disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516710

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Åsmund Avdem Fretland, MD, 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 4, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Not decided yet but results will be public no matter the outcome of the trial

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

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

ClinicalTrials.gov processed this record on February 20, 2017