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Trial Title:
Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study
NCT ID:
NCT01516710
Condition:
Secondary Malignant Neoplasm of Liver
Colorectal Neoplasms
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Colorectal Neoplasms
Liver Neoplasms
Liver Extracts
Conditions: Keywords:
Open liver resection
Laparoscopic liver resection
Colorectal cancer liver metastases
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Open liver resection
Description:
Patients will be operated with open liver resection for colorectal metastasis
Arm group label:
Open liver resection
Other name:
Open liver resection using standard technique:
Other name:
Ligasure
Other name:
CUSA
Other name:
Thunderbeat
Other name:
Autosonix
Other name:
SonoSurg
Other name:
Ultrasound
Intervention type:
Procedure
Intervention name:
Laparoscopic liver resection
Description:
Patients will be operated with laparoscopic liver resection
Arm group label:
Laparoscopic liver resection
Other name:
Laparoscopic liver resection using standardized technique:
Other name:
Ligasure
Other name:
CUSA
Other name:
Thunderbeat
Other name:
Autosonix
Other name:
SonoSurg
Other name:
Laparoscopic ultrasound
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital
Address:
City:
Oslo
Zip:
0424
Country:
Norway
Start date:
January 2012
Completion date:
December 2025
Lead sponsor:
Agency:
Oslo University Hospital
Agency class:
Other
Collaborator:
Agency:
Helse Sor-Ost
Agency class:
Other
Source:
Oslo University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01516710
