Status:
COMPLETED
The ORANGE II PLUS - Trial: Open Versus Laparoscopic Hemihepatectomy
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
University Hospital Southampton NHS Foundation Trust
University Hospital, Ghent
Conditions:
Liver Lesions Requiring Hemihepatectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The added value of the laparoscopic hemihepatectomy compared to the open hemihepatectomy has never been studied in a randomized controlled setting. Therefore, the multicenter international ORANGE II P...
Detailed Description
Liver resection for colorectal metastasis is the only potentially curative therapy and has become the standard of care in appropriately staged patients, offering 5-year survival rates of approximately...
Eligibility Criteria
Inclusion
- Patients requiring open or laparoscopic left / right hemihepatectomy, with or without the need for one additional hepatic wedge resection or metastasectomy, for accepted indications.
- Able to understand the nature of the study and what will be required of them.
- Men and non-pregnant, non-lactating women age 18 years and older.
- BMI between 18-35.
- Patients with ASA I-II-III.
Exclusion
- Inability to give written informed consent.
- Patients undergoing liver resection other than left or right hemihepatectomy, with or without the need for one additional hepatic wedge resection or metastasectomy.
- Patients with hepatic lesion(s), that are located with insufficient margin from vascular or biliary structures to be operated laparoscopically.
- Patients with ASA IV-V.
- Repeat hepatectomy.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2023
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01441856
Start Date
October 1 2013
End Date
December 4 2023
Last Update
May 18 2025
Active Locations (16)
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1
Erasmus Hospital
Brussels, Belgium
2
Ghent University Hospital
Ghent, Belgium
3
Jessa Hospital
Hasselt, Belgium
4
General Hospital Groeninge
Kortrijk, Belgium