ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection
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ClinicalTrials.gov Identifier: NCT03270917 |
Recruitment Status :
Recruiting
First Posted : September 1, 2017
Last Update Posted : November 27, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Surgery | Procedure: Parenchymal preserving postero-superior liver segment resection | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be randomised to either the open or the laparoscopic treatment arm. |
Masking: | Double (Participant, Investigator) |
Masking Description: | The patient, ward physician and research investigator are blinded to the treatment intervention. A large abdominal dressing will be used to cover the incision(s) until postoperative day 4. Obviously, the surgeon and anaesthesiology team can not be blinded. |
Primary Purpose: | Treatment |
Official Title: | The ORANGE SEGMENTS - Trial: an International Multicentre Randomized Controlled Trial of Open Versus Laparoscopic Parenchymal Preserving Postero-superior Liver Segment Resection |
Actual Study Start Date : | November 1, 2017 |
Estimated Primary Completion Date : | April 30, 2021 |
Estimated Study Completion Date : | December 31, 2024 |
Arm | Intervention/treatment |
---|---|
Open
Open liver surgery
|
Procedure: 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). |
Laparoscopy
Laparoscopic liver surgery
|
Procedure: 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). |
- Time to functional recovery [ Time Frame: expected average of 4-10 days ]Time until a patient is functionally recovered
- Hospital length of stay [ Time Frame: 30 days ]Total length of hospital stay
- Intraoperative blood loss [ Time Frame: during procedure ]Net intraoperative blood loss
- Operating time [ Time Frame: surgical time from incision until closure ]
- (Liver specific) morbidity [ Time Frame: 1 year ]Composite endpoint of liver specific morbidity (intra-abdominal bleeding, intra-abdominal abcess, ascites, postresectional liver failure, intra-operative mortality, bile leakage)
- Readmission percentage [ Time Frame: 1 year ]Total percentage of patients being readmitted
- Resection margin [ Time Frame: 1 year ]Residual tumor cells in resection border
- Quality of life [ Time Frame: 1 year ]The physical, social and emotional well-being of the patient
- Body image and cosmesis [ Time Frame: 1 year ]The aesthetic appearance of the scars associated with the operation and its influence on the patient self-view
- Reasons for delay of discharge after functional recovery [ Time Frame: 1 year ]All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.
- Incisional herniation [ Time Frame: 1 year ]Cicatricial hernia
- Hospital and societal costs [ Time Frame: 1 year ]All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.
- Time to adjuvant chemotherapy initiation [ Time Frame: 1 year ]The time it takes to start adjuvant chemotherapy after the patient has been operated
- Overall five-year survival [ Time Frame: 5 years ]Five-year survival

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270917
Contact: Christoph Kummerli, MD | +41763875744 | c.kummerli@soton.ac.uk | |
Contact: Zina Eminton | +447973551272 | z.b.eminton@soton.ac.uk |

Study Chair: | Mohammed Abu Hilal, Prof. | University Hospital Southampton NHS Foundation Trust | |
Study Chair: | John Primrose, Prof. | University Hospital Southampton NHS Foundation Trust |
Publications:
Responsible Party: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT03270917 |
Other Study ID Numbers: |
NL36215.068.11* |
First Posted: | September 1, 2017 Key Record Dates |
Last Update Posted: | November 27, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parenchymal preserving Postero-superior Laparoscopy Hepatectomy |