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Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study
Conditions
Secondary Malignant Neoplasm of Liver - Colorectal Neoplasms
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasms - Neoplasms, Second Primary
Conditions: Keywords
Open liver resection, Laparoscopic liver resection, Colorectal cancer liver metastases
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Open liver resection
Type: Procedure
Name: Laparoscopic liver resection
Type: Procedure
Overall Status
Recruiting
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.
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
http://www.trialsjournal.com/content/16/1/73
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- Peroperative diagnosis of non radically treatable disease
- 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
Location
Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital
Oslo, Norway
Status: Recruiting
Contact: Marianne Moe, Head nurse - +4723072529
Start Date
January 2012
Completion Date
December 2025
Sponsors
Oslo University Hospital
Source
Oslo University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page