Liver SurgeryNCT03270917
ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection
A study testing Parenchymal preserving postero-superior liver segment resection in people with Liver Surgery, run by Maastricht University Medical Center at 16 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Surgery
- What is being tested?
- Parenchymal preserving postero-superior liver segment resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 1 Nov 2017to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United Kingdom8 sites
Aintree University Hospital
Aintree
Queen Elizabeth Hospital
Birmingham
King's College Hospital
London
Manchester Royal Infirmary
Manchester
Freeman Hospital
Newcastle
Oxford University Hospitals
Oxford
Derriford Hospital
Plymouth
University Hospital Southampton
Southampton
Italy3 sites
Poliambulanza Hospital
Brescia
San Raffaele Hospital
Milan
San Camillo-Forlanini Hospital
Rome
Netherlands2 sites
Academic Medical Center
Amsterdam
Maastricht University Medical Center+
Maastricht
About this study
Official title: The ORANGE SEGMENTS - Trial: an International Multicentre Randomized Controlled Trial of Open Versus Laparoscopic Parenchymal Preserving Postero-superior Liver Segment Resection
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.
Read the 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 61% in selected cases, with approximately 30% of patients surviving ten years or more, compared to five-year survival rates of less than 5% for patients not amenable to resection. Liver surgery is also a widely accepted treatment for symptomatic benign lesions and those of uncertain nature or large size. Whilst the figures are a vast improvement on the past, there is still a need to refine the treatment of these patients, including surgical technique.
Open hepatectomy is the current standard of care for the management of primary and secondary tumours. The open postero-superior liver segment resection requires a large incision to achieve adequate access and proper control during resection. This has a significant impact on patient's recovery and, in cases of small resections, this access may represent the major component of surgical trauma. Advances in surgical technique and expertise now permit these operations to be performed with minor incisions by using the laparoscopic approach. Although the feasibility of laparoscopic hepatectomy has been established, only select centres use this technique as their primary modality.
Laparoscopic liver resection was first reported in 1991. Over the past decades, the method has gained wide acceptance for various liver resection procedures. Multiple retrospective case series, patient cohorts, systematic reviews and meta-analyses have compared open with laparoscopic liver surgery and indicate the laparoscopic approach to be safely applicable for the resection of both malignant and benign liver lesions. Laparoscopic liver resection has been associated with shorter hospital length of stay, reduced intraoperative blood loss, less postoperative pain and earlier recovery. Despite this, concerns remain over operative times, the ability to control haemorrhage laparascopically and long-term oncological outcomes.
Initially, the left lateral segments of the liver were chosen for anatomic laparoscopic resection, with good results. Many liver centres worldwide currently use laparoscopy for resection of the anterior liver segments. Whilst case control studies would now seem sufficient to allay such concerns in the context of minor liver resections and left lateral sectionectomies, the adoption and dissemination of laparoscopy by hepatobiliary oncologic surgeons for major hepatectomies and resections of postero-superior segments has been restricted. Besides the relatively low volume of patients, major laparoscopic liver resections are technically demanding, have a significant learning curve, are time consuming, are thought to hold an increased morbidity risk and lack in evidence.
Nevertheless, a new impulse for the laparoscopic management of major liver lesions came after the first reports of laparoscopic hemihepatectomies, which demonstrated that in expert hands major anatomical laparoscopic liver resections are feasible with good efficacy and safety. When comparing surgical procedures, one of the easiest to measure and often used outcomes is the length of hospital stay; the time it takes for a patient to be discharged from the hospital after an operation. On the whole, a median hospital length of stay of 6.0 to 13.1 days and 3.5 to 10.0 days have been observed after open and laparoscopic hepatic resections in European centres respectively. For major surgery in expert centres, median duration of hospital admission varied between 6 to 12.5 days for open surgery and 4 to 8.2 days for laparoscopic resections. Concentrating on postero-superior liver segment resections, the median hospital stay is 6 days (3-44 days) for those undergoing open compared with 4 days (1-11 days) for those having laparoscopic resections.
Besides the immediate benefits to the patient, such as decreased intraoperative blood loss, diminished postoperative pain, earlier recovery and reduced hospital length of stay, laparoscopic liver surgery may also have the potential to improve outcomes in the longer term by reducing complications, enhancing quality of life, improving cosmesis, ensuring early commencement and completion of adjuvant therapies. However, level-1 evidence on all outcomes is still to be presented.
Within the framework of optimized perioperative care, broader indications for hepatic surgery and further adoption of laparoscopic liver resections, there is a clear need for a randomized trial. Therefore, the multicentre and international ORANGE SEGMENTS - Trial has been designed to provide evidence on the merits of laparoscopic versus open parenchymal preserving postero-superior liver segment resection within an enhanced recovery programme in terms of time to functional recovery, hospital length of stay, intraoperative blood loss, operation time, resection margin, time to adjuvant chemotherapy initiation, readmission percentage, (liver specific) morbidity, quality of life, body image, reasons for delay of discharge after functional recovery, long term incidence of incisional hernias, hospital and societal costs during one year and overall five-year survival.
- Conditions
- Liver Surgery
- Being tested
- Parenchymal preserving postero-superior liver segment resection
- Keywords
- Parenchymal preserving, Postero-superior, Laparoscopy, Hepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenchymal preserving postero-superior liver segment resectionProcedure or surgery
Parenchymal preserving liver segment resection of one or two of the postero-superior liver segments (4A, 7 or 8).
| Study group | Role | What they receive |
|---|---|---|
| Open | Other | Open liver surgery Receives: Procedure: Parenchymal preserving postero-superior liver segment resection |
| Laparoscopy | Other | Laparoscopic liver surgery Receives: Procedure: Parenchymal preserving postero-superior liver segment resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to functional recovery
Time until a patient is functionally recovered
Measured: expected average of 4-10 days
Secondary outcomes (13)
Hospital length of stay
Total length of hospital stay
Measured: 30 days
Intraoperative blood loss
Net intraoperative blood loss
Measured: during procedure
Operating time
Measured: surgical time from incision until closure
(Liver specific) morbidity
Composite endpoint of liver specific morbidity (intra-abdominal bleeding, intra-abdominal abcess, ascites, postresectional liver failure, intra-operative mortality, bile leakage)
Measured: 1 year
Readmission percentage
Total percentage of patients being readmitted
Measured: 1 year
Resection margin
Residual tumor cells in resection border
Measured: 1 year
Quality of life
The physical, social and emotional well-being of the patient
Measured: 1 year
Body image and cosmesis
The aesthetic appearance of the scars associated with the operation and its influence on the patient self-view
Measured: 1 year
Reasons for delay of discharge after functional recovery
All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.
Measured: 1 year
Incisional herniation
Cicatricial hernia
Measured: 1 year
Hospital and societal costs
All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.
Measured: 1 year
Time to adjuvant chemotherapy initiation
The time it takes to start adjuvant chemotherapy after the patient has been operated
Measured: 1 year
Overall five-year survival
Five-year survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2021
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver SurgeryStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to either the open or the laparoscopic treatment arm.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), The Queen Elizabeth Hospital, General Hospital Groeninge, Liverpool University Hospitals NHS Foundation Trust, King's College Hospital NHS Trust, San Raffaele University Hospital, Italy, Newcastle-upon-Tyne Hospitals NHS Trust, Oslo University Hospital, Oxford University Hospitals NHS Trust, Derriford Hospital, University Hospital Southampton NHS Foundation Trust, Manchester University NHS Foundation Trust, Moscow Clinical Scientific Center, San Camillo Hospital, Rome, Fondazione Poliambulanza Istituto Ospedaliero, Federico II University
- Responsible party
- Sponsor
- Investigators
- Mohammed Abu Hilal, Prof., Study chair, University Hospital Southampton NHS Foundation TrustJohn Primrose, Prof., Study chair, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270917
- Sponsor's protocol ID
- NL36215.068.11*
- Status last verified
- May 2025
- First submitted
- 28 Aug 2017
- Last updated
- 19 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coles SR, Besselink MG, Serin KR, Alsaati H, Di Gioia P, Samim M, Pearce NW, Abu Hilal M. Total laparoscopic management of lesions involving liver segment 7. Surg Endosc. 2015 Nov;29(11):3190-5. doi: 10.1007/s00464-014-4052-2. Epub 2015 Jan 13.
PubMed 25582963Cipriani F, Shelat VG, Rawashdeh M, Francone E, Aldrighetti L, Takhar A, Armstrong T, Pearce NW, Abu Hilal M. Laparoscopic Parenchymal-Sparing Resections for Nonperipheral Liver Lesions, the Diamond Technique: Technical Aspects, Clinical Outcomes, and Oncologic Efficiency. J Am Coll Surg. 2015 Aug;221(2):265-72. doi: 10.1016/j.jamcollsurg.2015.03.029. Epub 2015 Mar 27.
PubMed 25899733Scuderi V, Barkhatov L, Montalti R, Ratti F, Cipriani F, Pardo F, Tranchart H, Dagher I, Rotellar F, Abu Hilal M, Edwin B, Vivarelli M, Aldrighetti L, Troisi RI. Outcome after laparoscopic and open resections of posterosuperior segments of the liver. Br J Surg. 2017 May;104(6):751-759. doi: 10.1002/bjs.10489. Epub 2017 Feb 13.
PubMed 28194774Zheng B, Zhao R, Li X, Li B. Comparison of laparoscopic liver resection for lesions located in anterolateral and posterosuperior segments: a meta-analysis. Surg Endosc. 2017 Nov;31(11):4641-4648. doi: 10.1007/s00464-017-5527-8. Epub 2017 Apr 7.
PubMed 28389796Sijberden JP, Kuemmerli C, Ratti F, D'Hondt M, Sutcliffe RP, Troisi RI, Efanov M, Fichtinger RS, Diaz-Nieto R, Ettorre GM, Sheen AJ, Menon KV, Besselink MG, Soonawalla Z, Aroori S, Marino R, De Meyere C, Marudanayagam R, Zimmitti G, Olij B, Eminton Z, Brandts L, Ferrari C, M van Dam R, Aldrighetti LA, Pugh S, Primrose JN, Abu Hilal M. Laparoscopic versus open parenchymal preserving liver resections in the posterosuperior segments (ORANGE Segments): a multicentre, single-blind, randomised controlled trial. Lancet Reg Health Eur. 2025 Feb 20;51:101228. doi: 10.1016/j.lanepe.2025.101228. eCollection 2025 Apr.
PubMed 40060302Kuemmerli C, Fichtinger RS, Moekotte A, Aldrighetti LA, Aroori S, Besselink MGH, D'Hondt M, Diaz-Nieto R, Edwin B, Efanov M, Ettorre GM, Menon KV, Sheen AJ, Soonawalla Z, Sutcliffe R, Troisi RI, White SA, Brandts L, van Breukelen GJP, Sijberden J, Pugh SA, Eminton Z, Primrose JN, van Dam R, Hilal MA; ORANGE trials collaborative. Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial. Trials. 2022 Mar 9;23(1):206. doi: 10.1186/s13063-022-06112-3.
PubMed 35264216
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ORANGE SEGMENTS - Trial: an International Multicentre Randomized Controlled Trial of Open Versus Laparoscopic Parenchymal Preserving Postero-superior Liver Segment Resection
- ClinicalTrials.gov ID
- NCT03270917
- Acronym / sponsor ID
- NL36215.068.11*
- Conditions
- Liver Surgery
- Keywords
- Parenchymal preserving, Postero-superior, Laparoscopy, Hepatectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), The Queen Elizabeth Hospital, General Hospital Groeninge, Liverpool University Hospitals NHS Foundation Trust, King's College Hospital NHS Trust, San Raffaele University Hospital, Italy, Newcastle-upon-Tyne Hospitals NHS Trust, Oslo University Hospital, Oxford University Hospitals NHS Trust, Derriford Hospital, University Hospital Southampton NHS Foundation Trust, Manchester University NHS Foundation Trust, Moscow Clinical Scientific Center, San Camillo Hospital, Rome, Fondazione Poliambulanza Istituto Ospedaliero, Federico II University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 61% in selected cases, with approximately 30% of patients surviving ten years or more, compared to five-year survival rates of less than 5% for patients not amenable to resection. Liver surgery is also a widely accepted treatment for symptomatic benign lesions and those of uncertain nature or large size. Whilst the figures are a vast improvement on the past, there is still a need to refine the treatment of these patients, including surgical technique.
Open hepatectomy is the current standard of care for the management of primary and secondary tumours. The open postero-superior liver segment resection requires a large incision to achieve adequate access and proper control during resection. This has a significant impact on patient's recovery and, in cases of small resections, this access may represent the major component of surgical trauma. Advances in surgical technique and expertise now permit these operations to be performed with minor incisions by using the laparoscopic approach. Although the feasibility of laparoscopic hepatectomy has been established, only select centres use this technique as their primary modality.
Laparoscopic liver resection was first reported in 1991. Over the past decades, the method has gained wide acceptance for various liver resection procedures. Multiple retrospective case series, patient cohorts, systematic reviews and meta-analyses have compared open with laparoscopic liver surgery and indicate the laparoscopic approach to be safely applicable for the resection of both malignant and benign liver lesions. Laparoscopic liver resection has been associated with shorter hospital length of stay, reduced intraoperative blood loss, less postoperative pain and earlier recovery. Despite this, concerns remain over operative times, the ability to control haemorrhage laparascopically and long-term oncological outcomes.
Initially, the left lateral segments of the liver were chosen for anatomic laparoscopic resection, with good results. Many liver centres worldwide currently use laparoscopy for resection of the anterior liver segments. Whilst case control studies would now seem sufficient to allay such concerns in the context of minor liver resections and left lateral sectionectomies, the adoption and dissemination of laparoscopy by hepatobiliary oncologic surgeons for major hepatectomies and resections of postero-superior segments has been restricted. Besides the relatively low volume of patients, major laparoscopic liver resections are technically demanding, have a significant learning curve, are time consuming, are thought to hold an increased morbidity risk and lack in evidence.
Nevertheless, a new impulse for the laparoscopic management of major liver lesions came after the first reports of laparoscopic hemihepatectomies, which demonstrated that in expert hands major anatomical laparoscopic liver resections are feasible with good efficacy and safety. When comparing surgical procedures, one of the easiest to measure and often used outcomes is the length of hospital stay; the time it takes for a patient to be discharged from the hospital after an operation. On the whole, a median hospital length of stay of 6.0 to 13.1 days and 3.5 to 10.0 days have been observed after open and laparoscopic hepatic resections in European centres respectively. For major surgery in expert centres, median duration of hospital admission varied between 6 to 12.5 days for open surgery and 4 to 8.2 days for laparoscopic resections. Concentrating on postero-superior liver segment resections, the median hospital stay is 6 days (3-44 days) for those undergoing open compared with 4 days (1-11 days) for those having laparoscopic resections.
Besides the immediate benefits to the patient, such as decreased intraoperative blood loss, diminished postoperative pain, earlier recovery and reduced hospital length of stay, laparoscopic liver surgery may also have the potential to improve outcomes in the longer term by reducing complications, enhancing quality of life, improving cosmesis, ensuring early commencement and completion of adjuvant therapies. However, level-1 evidence on all outcomes is still to be presented.
Within the framework of optimized perioperative care, broader indications for hepatic surgery and further adoption of laparoscopic liver resections, there is a clear need for a randomized trial. Therefore, the multicentre and international ORANGE SEGMENTS - Trial has been designed to provide evidence on the merits of laparoscopic versus open parenchymal preserving postero-superior liver segment resection within an enhanced recovery programme in terms of time to functional recovery, hospital length of stay, intraoperative blood loss, operation time, resection margin, time to adjuvant chemotherapy initiation, readmission percentage, (liver specific) morbidity, quality of life, body image, reasons for delay of discharge after functional recovery, long term incidence of incisional hernias, hospital and societal costs during one year and overall five-year survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomised to either the open or the laparoscopic treatment arm.
| Arm | Type | Receives |
|---|---|---|
| Open | Other | Procedure: Parenchymal preserving postero-superior liver segment resectionOpen liver surgery |
| Laparoscopy | Other | Procedure: Parenchymal preserving postero-superior liver segment resectionLaparoscopic liver surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenchymal preserving postero-superior liver segment resectionParenchymal preserving liver segment resection of one or two of the postero-superior liver segments (4A, 7 or 8). | Procedure or surgery | Laparoscopy, Open |
Primary outcome
Time to functional recovery
Time frame: expected average of 4-10 days
Time until a patient is functionally recovered
13 secondary outcomes
Hospital length of stay
Time frame: 30 days
Intraoperative blood loss
Time frame: during procedure
Operating time
Time frame: surgical time from incision until closure
(Liver specific) morbidity
Time frame: 1 year
Readmission percentage
Time frame: 1 year
Resection margin
Time frame: 1 year
Quality of life
Time frame: 1 year
Body image and cosmesis
Time frame: 1 year
Reasons for delay of discharge after functional recovery
Time frame: 1 year
Incisional herniation
Time frame: 1 year
Hospital and societal costs
Time frame: 1 year
Time to adjuvant chemotherapy initiation
Time frame: 1 year
Overall five-year survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2025.
- Background: PubMed 25582963Coles SR, Besselink MG, Serin KR, Alsaati H, Di Gioia P, Samim M, Pearce NW, Abu Hilal M. Total laparoscopic management of lesions involving liver segment 7. Surg Endosc. 2015 Nov;29(11):3190-5. doi: 10.1007/s00464-014-4052-2. Epub 2015 Jan 13.
- Background: PubMed 25899733Cipriani F, Shelat VG, Rawashdeh M, Francone E, Aldrighetti L, Takhar A, Armstrong T, Pearce NW, Abu Hilal M. Laparoscopic Parenchymal-Sparing Resections for Nonperipheral Liver Lesions, the Diamond Technique: Technical Aspects, Clinical Outcomes, and Oncologic Efficiency. J Am Coll Surg. 2015 Aug;221(2):265-72. doi: 10.1016/j.jamcollsurg.2015.03.029. Epub 2015 Mar 27.
- Background: PubMed 28194774Scuderi V, Barkhatov L, Montalti R, Ratti F, Cipriani F, Pardo F, Tranchart H, Dagher I, Rotellar F, Abu Hilal M, Edwin B, Vivarelli M, Aldrighetti L, Troisi RI. Outcome after laparoscopic and open resections of posterosuperior segments of the liver. Br J Surg. 2017 May;104(6):751-759. doi: 10.1002/bjs.10489. Epub 2017 Feb 13.
- Background: PubMed 28389796Zheng B, Zhao R, Li X, Li B. Comparison of laparoscopic liver resection for lesions located in anterolateral and posterosuperior segments: a meta-analysis. Surg Endosc. 2017 Nov;31(11):4641-4648. doi: 10.1007/s00464-017-5527-8. Epub 2017 Apr 7.
- Derived from this study: PubMed 40060302Sijberden JP, Kuemmerli C, Ratti F, D'Hondt M, Sutcliffe RP, Troisi RI, Efanov M, Fichtinger RS, Diaz-Nieto R, Ettorre GM, Sheen AJ, Menon KV, Besselink MG, Soonawalla Z, Aroori S, Marino R, De Meyere C, Marudanayagam R, Zimmitti G, Olij B, Eminton Z, Brandts L, Ferrari C, M van Dam R, Aldrighetti LA, Pugh S, Primrose JN, Abu Hilal M. Laparoscopic versus open parenchymal preserving liver resections in the posterosuperior segments (ORANGE Segments): a multicentre, single-blind, randomised controlled trial. Lancet Reg Health Eur. 2025 Feb 20;51:101228. doi: 10.1016/j.lanepe.2025.101228. eCollection 2025 Apr.
- Derived from this study: PubMed 35264216Kuemmerli C, Fichtinger RS, Moekotte A, Aldrighetti LA, Aroori S, Besselink MGH, D'Hondt M, Diaz-Nieto R, Edwin B, Efanov M, Ettorre GM, Menon KV, Sheen AJ, Soonawalla Z, Sutcliffe R, Troisi RI, White SA, Brandts L, van Breukelen GJP, Sijberden J, Pugh SA, Eminton Z, Primrose JN, van Dam R, Hilal MA; ORANGE trials collaborative. Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial. Trials. 2022 Mar 9;23(1):206. doi: 10.1186/s13063-022-06112-3.
- The ORANGE - Trials consortium webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Abu Hilal, Prof. study chair
University Hospital Southampton NHS Foundation Trust
John Primrose, Prof. study chair
University Hospital Southampton NHS Foundation Trust
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenchymal preserving postero-superior liver segment resection in people with Liver Surgery, run by Maastricht University Medical Center at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom, Italy, Netherlands, Belgium, Norway and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to functional recovery (time frame: expected average of 4-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270917, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2025.