Status:
ACTIVE_NOT_RECRUITING
ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
The Queen Elizabeth Hospital
Conditions:
Liver Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The international and multicentre ORANGE SEGMENTS - Trial is a prospective, double blinded, randomized controlled study comparing patients undergoing parenchymal preserving resection of postero-superi...
Detailed Description
Liver resection for colorectal metastasis is a potential curative therapy and has become the standard of care in appropriately staged patients, offering five-year survival rates ranging from 38 up to ...
Eligibility Criteria
Inclusion
- Patients requiring a parenchymal sparing liver resection (including wedge resections and full segmentectomies) involving one or two of segments 4a/7/8 for accepted indications . A segment 6/7 resection would also be eligible.
- Able to understand the nature of the study and what will be required of them.
- Men and non-pregnant, non-lactating women, aged 18 years and older.
- BMI between and including 18-35 kg/m2
- Patients with ASA physical status I-II-III.
Exclusion
- Inability to give (written) informed consent.
- Patients requiring other liver surgery than a parenchymal sparing resection involving one or two of segments 4a, 7, 8.
- Patients requiring parenchymal sparing liver resection involving segment 1. This is due to the high level of technical difficulty.
- Patients with hepatic lesion(s), that are located with insufficient margin from vascular or biliary structures to be operated laparoscopically.
- Patients with ASA physical status IV-V.
- Repeat hepatectomy.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03270917
Start Date
November 1 2017
End Date
November 1 2026
Last Update
May 19 2025
Active Locations (16)
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1
General Hospital Groeninge
Kortrijk, Belgium
2
Poliambulanza Hospital
Brescia, Italy
3
San Raffaele Hospital
Milan, Italy
4
San Camillo-Forlanini Hospital
Rome, Italy