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Secondary Malignant Neoplasm of LiverOslo-CoMetNCT01516710

Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

A study testing Open liver resection and Laparoscopic liver resection in people with Secondary Malignant Neoplasm of Liver and Colorectal Neoplasms, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Open liver resection and Laparoscopic liver resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteNorway
Study dates
Jan 2012to Dec 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

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

    Oslo, 0424

Other trials in Norway

About this study

Official title: 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.

Read the detailed description

Full protocol is published open access in Trialsjournal:

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

Being tested
Open liver resection, Laparoscopic liver resection
Keywords
Open liver resection, Laparoscopic liver resection, Colorectal cancer liver metastases
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open liver resectionProcedure or surgery

    Also called Open liver resection using standard technique:, Ligasure, CUSA, Thunderbeat

    Patients will be operated with open liver resection for colorectal metastasis

  • Laparoscopic liver resectionProcedure or surgery

    Also called Laparoscopic liver resection using standardized technique:, Ligasure, CUSA, Thunderbeat

    Patients will be operated with laparoscopic liver resection

Study groups in NCT01516710
Study groupRoleWhat they receive
Open liver resectionActive comparatorPatients will be operated with open liver resection
Receives: Procedure: Open liver resection
Laparoscopic liver resectionActive comparatorPatients will be operated with laparoscopic liver resection
Receives: Procedure: Laparoscopic liver resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30 Days 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

    Measured: Within 30 days after surgery

Secondary outcomes (15)

  1. 5 Year Survival

    5 year survival

    • overall
    • disease free
    • recurrence free

    Measured: 5 years after surgery

  2. 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.

    Measured: 5 years

  3. Immediate Oncologic Outcome

    Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.

    Measured: 2 months after surgery

  4. 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

    Measured: Up to 2 years

  5. 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.

    Measured: 72 hours

  6. Health Economy

    We intend to compare overall cost of treatment for the hospital and for the health care system

    Measured: 1 year

  7. 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.

    Measured: 4 months

  8. 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.

    Measured: 20 years

  9. Anti-tumor Immunology

    The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors

    Measured: 20 years

  10. 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.

    Measured: 5 years

  11. Severity of Morbidity

    Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system

    Measured: 30 days

  12. 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.

    Measured: 2 years

  13. 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.

    Measured: 1 year

  14. Readmissions

    Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.

    Measured: 30 days

  15. Incidence of Incisional Hernia

    CT scans will be performed to examine for incisional hernia 1 year after surgery

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionApr 2016
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516710
Sponsor's protocol ID
2011/1285/REK sør-øst B
Acronym
Oslo-CoMet
Status last verified
Nov 2023
First submitted
13 Jan 2012
Last updated
10 May 2024
Data monitoring committee
No
Individual data sharing
Yes: Not decided yet but results will be public no matter the outcome of the trial

Publications

  • Drejian S, Akhavi MS, Grzyb K, Kazaryan A, Fretland AA, Edwin B, Aghayan D. Histopathologic growth patterns as prognostic factor for survival in patients with colorectal liver metastases. Radiol Oncol. 2026 Feb 6;60(1):114-123. doi: 10.2478/raon-2026-0002. eCollection 2026 Mar 1.

    PubMed 41686533

  • 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.

    PubMed 33197213

  • 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.

    PubMed 31322735

  • 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.

    PubMed 25872027

Questions about this trial

What is this clinical trial studying?

A study testing Open liver resection and Laparoscopic liver resection in people with Secondary Malignant Neoplasm of Liver and Colorectal Neoplasms, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30 Days Perioperative Morbidity (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516710, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.

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