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Clinical Trials in Belgium / NCT03270917
Active, not recruiting Not applicable

ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection

NCT03270917 · tracked via the Priya Life Science Belgium tracker
Sponsor
Maastricht University Medical Center
Phase
Not applicable
Started
2017-11-01
Last updated
2025-05-19

Condition(s) studied

Liver Surgery

Investigational drug(s) / intervention(s)

Parenchymal preserving postero-superior liver segment resection

Parenchymal preserving postero-superior liver segment resection: Parenchymal preserving liver segment resection of one or two of the postero-superior liver segments (4A, 7 or 8).

Study summary

The international and multicentre ORANGE SEGMENTS - Trial is a prospective, double blinded, randomized controlled study comparing patients undergoing parenchymal preserving resection of postero-superior liver segments (involving one or two of segments 4a, 7, 8). All patients will be participating in an enhanced recovery programme.

Primary outcome is time to functional recovery. Secondary study parameters include hospital length of stay, intraoperative blood loss, operation time, liver specific morbidity, readmission percentage, resection margin, quality of life, body image and cosmesis , reasons for delay of discharge after functional recovery, long term incidence of incisional hernias, hospital and societal costs during one year, time to adjuvant chemotherapy initiation, overall five-year survival.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
General Hospital Groeninge Kortrijk Belgium
Poliambulanza Hospital Brescia Italy
San Raffaele Hospital Milan Italy
San Camillo-Forlanini Hospital Rome Italy
Academic Medical Center Amsterdam Netherlands
Maastricht University Medical Center+ Maastricht Netherlands
University Hospital Oslo Oslo Norway
Moscow Clinical Scientific Center Moscow Russia
Aintree University Hospital Aintree United Kingdom
Queen Elizabeth Hospital Birmingham United Kingdom
King's College Hospital London United Kingdom
Manchester Royal Infirmary Manchester United Kingdom
Freeman Hospital Newcastle United Kingdom
Oxford University Hospitals Oxford United Kingdom
Derriford Hospital Plymouth United Kingdom
University Hospital Southampton Southampton United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03270917 on ClinicalTrials.gov ↗ ← All trials in Belgium