Clinical trial NCT01516710: Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study
Official title: Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Secondary Malignant Neoplasm of Liver
Colorectal Neoplasms
Keywords: Open liver resection
Laparoscopic liver resection
Colorectal cancer liver metastases
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
First posted: 2012-01-25
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 30 Days Perioperative Morbidity
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: 5 Year Survival
timeFrame: 5 years after surgery
measure: Recurrence Pattern
timeFrame: 5 years
measure: Immediate Oncologic Outcome
timeFrame: 2 months after surgery
measure: Postoperative Quality of Life
timeFrame: Up to 2 years
measure: Surgical Trauma and Activation of the Immune System
timeFrame: 72 hours
measure: Health Economy
timeFrame: 1 year
measure: Severity of Postoperative Pain
timeFrame: 4 months
measure: Molecular Biology
timeFrame: 20 years
measure: Anti-tumor Immunology
timeFrame: 20 years
measure: Imaging
timeFrame: 5 years
measure: Severity of Morbidity
timeFrame: 30 days
measure: Level of Adhesions
timeFrame: 2 years
measure: Number of Patients That Complete Adjuvant Oncologic Treatment
timeFrame: 1 year
measure: Readmissions
timeFrame: 30 days
measure: Incidence of Incisional Hernia
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital
Study officials:
affiliation: Oslo University Hospital - The Interventional Centre
name: Bjørn Edwin, MD, PhD
role: STUDY_CHAIR
affiliation: Oslo University Hospital - The Interventional Centre
name: Bjorn Edwin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.