Liver Lesions Requiring HemihepatectomyNCT01441856
The ORANGE II PLUS - Trial: Open Versus Laparoscopic Hemihepatectomy
A study testing Open or Laparoscopic left hemihepatectomy and Open or Laparoscopic right hemihepatectomy in people with Liver Lesions Requiring Hemihepatectomy, run by Maastricht University Medical Center at 16 sites in 6 countries.
Trial 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 PLUS - trial has been constructed and will provide evidence on the merits of laparoscopic versus open hemihepatectomy in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Lesions Requiring Hemihepatectomy
- What is being tested?
- Open or Laparoscopic left hemihepatectomy and Open or Laparoscopic right hemihepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 1 Oct 2013to 4 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United Kingdom7 sites
Aintree University Hospital
Aintree
Queen Elizabeth Hospital
Birmingham
King's College Hospital
London
Freeman Hospital
Newcastle
Oxford University Hospitals
Oxford
Derriford Hospital
Plymouth
University Hospital Southampton
Southampton
Belgium4 sites
Erasmus Hospital
Brussels
Ghent University Hospital
Ghent
Jessa Hospital
Hasselt
General Hospital Groeninge
Kortrijk
Netherlands2 sites
Academic Medical Center
Amsterdam
Maastricht University Medical Center+
Maastricht
About this study
Official title: The ORANGE II PLUS - Trial: an International Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Hemihepatectomies.
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 PLUS - trial has been constructed and will provide evidence on the merits of laparoscopic versus open hemihepatectomy 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.
Read the 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 35-40%. Also for symptomatic benign lesions and those of uncertain nature or large size, liver resection is a widely accepted treatment. Open hepatectomy (OH) is the current standard of care for the management of primary and secondary malignancies. Although the feasibility of laparoscopic hepatectomy (LH) has been established, only select centres have used this technique as their primary modality.
Laparoscopic liver resection was first reported in 1991. Over the last decade the method has gained wide acceptance for various liver resection procedures. Multiple retrospective case series and reviews comparing open with laparoscopic liver resection indicate that laparoscopic liver resection can be applied safely for 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, earlier recovery and better quality of life. Initially the left lateral segments of the liver were chosen for anatomic laparoscopic resection with good results. Many liver centres worldwide are currently adopting laparoscopic surgery for resection of anterior segments, but relatively low volumes to operate on, a significant learning curve and lack of evidence restrict the majority of liver surgeons to further adopt and disseminate this technique.
Recently, indications for resectability have been broadened by new (neo)adjuvant chemotherapies and (radio)embolisation techniques. A new impulse for the laparoscopic management of liver lesions came after the first reports of laparoscopic hemihepatectomies. Major hepatic resections can be technically demanding and hold an increased risk for morbidity. It was demonstrated that in expert hands major anatomical laparoscopic liver resections were feasible with good efficacy and safety. Expert liver centers are already performing laparoscopic (extended) hemihepatectomies. Currently, in European centers, a median hospital length of stay of 6.0 to 13.1 and 3.5 to 10.0 days is observed after respectively open and laparoscopic hepatic resection. In expert hands median duration of admission after major hepatic resection varies between 6 - 12.5 for open and 4 - 8.2 for laparoscopic surgery. However, reports are scarce and level 1 evidence on this matter is still to be presented.
Within the framework of optimising postoperative recovery, broader indications for resection and further adoption of laparoscopic liver surgery there is a need for a randomized trial.Regarding postoperative care, enthusiasm has arisen for the Enhanced Recovery After Surgery (ERAS®) program. This multimodal program, derived from Kehlet's 1990's pioneer work in the multimodal surgical care field, involves optimization of several aspects of the perioperative management of patients undergoing major abdominal surgery. In patients undergoing segmental colectomy, the ERAS® -program enabled earlier recovery and consequently shorter hospital length of stay. Furthermore, a reduction of postoperative morbidity in patients undergoing intestinal resection was reported. These results stimulated liver surgeons of the ERAS® group (Maastricht, Edinburgh and Tromsö) to adapt the ERAS®-program to patients undergoing open liver resection. Van Dam et al. found a significantly reduced hospital length of stay after open liver resection when patients were managed within a multimodal ERAS®-program. Besides a reduction of median total hospital length of stay from 8 to 6 days (25%), the data also suggested that a further reduction of stay could be possible as there was a delay between recovery and actual discharge of the patients. Moreover, Stoot et al. showed - retrospectively - a further reduction in length of stay from 7 days to 5 days when patients were operated laparoscopically and managed within an ERAS®-program. In this study there was also a delay between recovery and actual discharge of the patients. Earlier, Maessen et al. reported a median delay to discharge of 2 days after patients had functionally recovered from colonic surgery managed within an ERAS®-program. This delay is often linked to social problems, problems in homecare support or logistic problems.
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 PLUS - trial has been constructed and will provide evidence on the merits of laparoscopic versus open hemihepatectomy.
- Conditions
- Liver Lesions Requiring Hemihepatectomy
- Being tested
- Open or Laparoscopic left hemihepatectomy, Open or Laparoscopic right hemihepatectomy
- Keywords
- Open, Laparoscopic, Hemihepatectomy, Hepatectomy, Enhanced Recovery After Surgery, Functional recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open or Laparoscopic left hemihepatectomyProcedure or surgery
Patients in this arm will undergo a left hemihepatectomy within an Enhanced Recovery After Surgery Program.
Open or Laparoscopic right hemihepatectomyProcedure or surgery
Patients in this arm will undergo a right hemihepatectomy within an Enhanced Recovery After Surgery Program.
| Study group | Role | What they receive |
|---|---|---|
| Open or Laparocopic Left | Active comparator | Open or Laparoscopic left hemihepatectomy Receives: Procedure: Open or Laparoscopic left hemihepatectomy |
| Open or Laparoscopic Right | Active comparator | Open or Laparoscopic right hemihepatectomy Receives: Procedure: Open or Laparoscopic right hemihepatectomy |
| Prospective registry | Active comparator | Prospective registry of patients that cannot be randomized (both open and laparoscopic left + right hemihepatectomy) Receives: Procedure: Open or Laparoscopic left hemihepatectomy; Procedure: Open or Laparoscopic right hemihepatectomy |
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 (15)
Length of hospital stay
Total length of hospital stay
Measured: 30 days
Readmission percentage
Total percentage of patients being readmitted
Measured: 1 year
Total morbidity
Total morbidity during one year
Measured: 1 year
Composite endpoint of 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
Long term incidence of incisional hernia
Incidence of incisional hernia after 1 year
Measured: 1 year
Quality of life: QLQ-C30 + LM 21
Quality of life assessment (QLQ-C30 + LM 21) during one year
Measured: 1 year
Body image and cosmesis
Influence of intervention on body image and cosmesis during one year
Measured: 1 year
Reasons for delay in discharge after functional recovery
Measured: 1 year
Intraoperative blood loss
Measured: During procedure
Intraoperative time
Measured: Surgical time from incision to closure
Resection margin
Measured: During pathology assessment
Time to adjuvant chemotherapy initiation
Measured: 1 year
Disease-free survival
Measured: 1 year
Hospital and societal costs
Measured: 1 year
Overall survival
Measured: 1 year and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study start1 Oct 2013
- Primary completion4 Dec 2019
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver Lesions Requiring HemihepatectomyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust, University Hospital, Ghent, San Raffaele University Hospital, Italy, Derriford Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Queen Elizabeth Hospital NHS Foundation Trust, King's College London, Newcastle-upon-Tyne Hospitals NHS Trust, Oslo University Hospital, General Hospital Groeninge, Jessa Hospital, Universitair Ziekenhuis Brussel, University Hospital, Aachen, Liverpool University Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- R.M. van Dam, MD PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441856
- Sponsor's protocol ID
- NL36215.068.11
- Status last verified
- May 2025
- First submitted
- 27 Apr 2011
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Olij B, Pilz da Cunha G, Ratti F, Abu Hilal M, Troisi RI, Sutcliffe RP, Besselink MG, Aroori S, Menon KV, Edwin B, D'Hondt M, Lucidi V, Ulmer TF, Diaz-Nieto R, Soonawalla Z, White S, Sergeant G, Kuemmerli C, Korenblik R, Scuderi V, Berrevoet F, Vanlander A, Marudanayagam R, Tanis PJ, Coolsen MME, Fichtinger RS, Eminton ZB, Neumann UP, Brandts L, Pugh SA, Fretland AA, Primrose JN, van Dam RM; ORANGE II PLUS Collaborative. Laparoscopic versus open hemihepatectomy: does side matter? A post-hoc analysis of the ORANGE II PLUS randomized controlled trial. Surg Endosc. 2026 May;40(5):4195-4205. doi: 10.1007/s00464-026-12588-w. Epub 2026 Mar 9.
PubMed 41803352Olij B, Pilz da Cunha G, Kimman M, Ratti F, Abu Hilal M, Troisi RI, Sutcliffe RP, Besselink MG, Aroori S, Menon KV, Edwin B, D'Hondt M, Lucidi V, Ulmer TF, Diaz-Nieto R, Soonawalla Z, White S, Sergeant G, Coolsen MME, Kuemmerli C, Scuderi V, Berrevoet F, Vanlander A, Marudanayagam R, Tanis PJ, Dewulf MJL, Fichtinger RS, Eminton ZB, Neumann UP, Brandts L, Pugh SA, Fretland AA, Primrose JN, van Dam RM; ORANGE II PLUS Collaborative. Healthcare Utilization, Costs, and Cost-Effectiveness of Patients Undergoing Laparoscopic and Open Hemihepatectomy: A Secondary Analysis of the ORANGE II PLUS Randomized Controlled, Phase 3, Superiority Trial. Ann Surg Oncol. 2026 Apr;33(4):2882-2898. doi: 10.1245/s10434-025-18779-4. Epub 2025 Dec 12.
PubMed 41385067Olij B, Fichtinger RS, Aldrighetti LA, Abu Hilal M, Troisi RI, Sutcliffe RP, Besselink MG, Aroori S, Menon KV, Edwin B, D'Hondt M, Lucidi V, Ulmer TF, Diaz-Nieto R, Soonawalla Z, White S, Sergeant G, Ratti F, Kuemmerli C, Scuderi V, Berrevoet F, Vanlander A, Marudanayagam R, Tanis PJ, Dewulf MJL, Eminton ZB, Neumann UP, Brandts L, Pugh SA, Fretland AA, Kimman ML, Primrose JN, van Dam RM; ORANGE II PLUS Collaborative. Health-related quality of life in patients undergoing laparoscopic versus open hemihepatectomy: a secondary analysis of the ORANGE II PLUS randomised controlled, phase 3, superiority trial. Lancet Reg Health Eur. 2025 May 19;54:101311. doi: 10.1016/j.lanepe.2025.101311. eCollection 2025 Jul.
PubMed 40491830Fichtinger RS, Aldrighetti LA, Abu Hilal M, Troisi RI, Sutcliffe RP, Besselink MG, Aroori S, Menon KV, Edwin B, D'Hondt M, Lucidi V, Ulmer TF, Diaz-Nieto R, Soonawalla Z, White S, Sergeant G, Olij B, Ratti F, Kuemmerli C, Scuderi V, Berrevoet F, Vanlander A, Marudanayagam R, Tanis P, Dewulf MJL, Dejong CHC, Eminton Z, Kimman ML, Brandts L, Neumann UP, Fretland AA, Pugh SA, van Breukelen GJP, Primrose JN, van Dam RM; ORANGE II PLUS Collaborative. Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial. J Clin Oncol. 2024 May 20;42(15):1799-1809. doi: 10.1200/JCO.23.01019. Epub 2024 Apr 19.
PubMed 38640453
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ORANGE II PLUS - Trial: an International Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Hemihepatectomies.
- ClinicalTrials.gov ID
- NCT01441856
- Acronym / sponsor ID
- NL36215.068.11
- Conditions
- Liver Lesions Requiring Hemihepatectomy
- Keywords
- Open, Laparoscopic, Hemihepatectomy, Hepatectomy, Enhanced Recovery After Surgery, Functional recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust, University Hospital, Ghent, San Raffaele University Hospital, Italy, Derriford Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Queen Elizabeth Hospital NHS Foundation Trust, King's College London, Newcastle-upon-Tyne Hospitals NHS Trust, Oslo University Hospital, General Hospital Groeninge, Jessa Hospital, Universitair Ziekenhuis Brussel, University Hospital, Aachen, Liverpool University Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 28 Sep 2011 (estimated)
- 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 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 PLUS - trial has been constructed and will provide evidence on the merits of laparoscopic versus open hemihepatectomy 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.
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 35-40%. Also for symptomatic benign lesions and those of uncertain nature or large size, liver resection is a widely accepted treatment. Open hepatectomy (OH) is the current standard of care for the management of primary and secondary malignancies. Although the feasibility of laparoscopic hepatectomy (LH) has been established, only select centres have used this technique as their primary modality.
Laparoscopic liver resection was first reported in 1991. Over the last decade the method has gained wide acceptance for various liver resection procedures. Multiple retrospective case series and reviews comparing open with laparoscopic liver resection indicate that laparoscopic liver resection can be applied safely for 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, earlier recovery and better quality of life. Initially the left lateral segments of the liver were chosen for anatomic laparoscopic resection with good results. Many liver centres worldwide are currently adopting laparoscopic surgery for resection of anterior segments, but relatively low volumes to operate on, a significant learning curve and lack of evidence restrict the majority of liver surgeons to further adopt and disseminate this technique.
Recently, indications for resectability have been broadened by new (neo)adjuvant chemotherapies and (radio)embolisation techniques. A new impulse for the laparoscopic management of liver lesions came after the first reports of laparoscopic hemihepatectomies. Major hepatic resections can be technically demanding and hold an increased risk for morbidity. It was demonstrated that in expert hands major anatomical laparoscopic liver resections were feasible with good efficacy and safety. Expert liver centers are already performing laparoscopic (extended) hemihepatectomies. Currently, in European centers, a median hospital length of stay of 6.0 to 13.1 and 3.5 to 10.0 days is observed after respectively open and laparoscopic hepatic resection. In expert hands median duration of admission after major hepatic resection varies between 6 - 12.5 for open and 4 - 8.2 for laparoscopic surgery. However, reports are scarce and level 1 evidence on this matter is still to be presented.
Within the framework of optimising postoperative recovery, broader indications for resection and further adoption of laparoscopic liver surgery there is a need for a randomized trial.Regarding postoperative care, enthusiasm has arisen for the Enhanced Recovery After Surgery (ERAS®) program. This multimodal program, derived from Kehlet's 1990's pioneer work in the multimodal surgical care field, involves optimization of several aspects of the perioperative management of patients undergoing major abdominal surgery. In patients undergoing segmental colectomy, the ERAS® -program enabled earlier recovery and consequently shorter hospital length of stay. Furthermore, a reduction of postoperative morbidity in patients undergoing intestinal resection was reported. These results stimulated liver surgeons of the ERAS® group (Maastricht, Edinburgh and Tromsö) to adapt the ERAS®-program to patients undergoing open liver resection. Van Dam et al. found a significantly reduced hospital length of stay after open liver resection when patients were managed within a multimodal ERAS®-program. Besides a reduction of median total hospital length of stay from 8 to 6 days (25%), the data also suggested that a further reduction of stay could be possible as there was a delay between recovery and actual discharge of the patients. Moreover, Stoot et al. showed - retrospectively - a further reduction in length of stay from 7 days to 5 days when patients were operated laparoscopically and managed within an ERAS®-program. In this study there was also a delay between recovery and actual discharge of the patients. Earlier, Maessen et al. reported a median delay to discharge of 2 days after patients had functionally recovered from colonic surgery managed within an ERAS®-program. This delay is often linked to social problems, problems in homecare support or logistic problems.
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 PLUS - trial has been constructed and will provide evidence on the merits of laparoscopic versus open hemihepatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open or Laparocopic Left | Active comparator | Procedure: Open or Laparoscopic left hemihepatectomyOpen or Laparoscopic left hemihepatectomy |
| Open or Laparoscopic Right | Active comparator | Procedure: Open or Laparoscopic right hemihepatectomyOpen or Laparoscopic right hemihepatectomy |
| Prospective registry | Active comparator | Procedure: Open or Laparoscopic left hemihepatectomy, Procedure: Open or Laparoscopic right hemihepatectomyProspective registry of patients that cannot be randomized (both open and laparoscopic left + right hemihepatectomy) |
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 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Open or Laparoscopic left hemihepatectomyPatients in this arm will undergo a left hemihepatectomy within an Enhanced Recovery After Surgery Program. | Procedure or surgery | Open or Laparocopic Left, Prospective registry |
| Open or Laparoscopic right hemihepatectomyPatients in this arm will undergo a right hemihepatectomy within an Enhanced Recovery After Surgery Program. | Procedure or surgery | Open or Laparoscopic Right, Prospective registry |
Primary outcome
Time to functional recovery
Time frame: expected average of 4-10 days
Time until a patient is functionally recovered
15 secondary outcomes
Length of hospital stay
Time frame: 30 days
Readmission percentage
Time frame: 1 year
Total morbidity
Time frame: 1 year
Composite endpoint of liver specific morbidity
Time frame: 1 year
Long term incidence of incisional hernia
Time frame: 1 year
Quality of life: QLQ-C30 + LM 21
Time frame: 1 year
Body image and cosmesis
Time frame: 1 year
Reasons for delay in discharge after functional recovery
Time frame: 1 year
Intraoperative blood loss
Time frame: During procedure
Intraoperative time
Time frame: Surgical time from incision to closure
Resection margin
Time frame: During pathology assessment
Time to adjuvant chemotherapy initiation
Time frame: 1 year
Disease-free survival
Time frame: 1 year
Hospital and societal costs
Time frame: 1 year
Overall survival
Time frame: 1 year and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 41803352Olij B, Pilz da Cunha G, Ratti F, Abu Hilal M, Troisi RI, Sutcliffe RP, Besselink MG, Aroori S, Menon KV, Edwin B, D'Hondt M, Lucidi V, Ulmer TF, Diaz-Nieto R, Soonawalla Z, White S, Sergeant G, Kuemmerli C, Korenblik R, Scuderi V, Berrevoet F, Vanlander A, Marudanayagam R, Tanis PJ, Coolsen MME, Fichtinger RS, Eminton ZB, Neumann UP, Brandts L, Pugh SA, Fretland AA, Primrose JN, van Dam RM; ORANGE II PLUS Collaborative. Laparoscopic versus open hemihepatectomy: does side matter? A post-hoc analysis of the ORANGE II PLUS randomized controlled trial. Surg Endosc. 2026 May;40(5):4195-4205. doi: 10.1007/s00464-026-12588-w. Epub 2026 Mar 9.
- Derived from this study: PubMed 41385067Olij B, Pilz da Cunha G, Kimman M, Ratti F, Abu Hilal M, Troisi RI, Sutcliffe RP, Besselink MG, Aroori S, Menon KV, Edwin B, D'Hondt M, Lucidi V, Ulmer TF, Diaz-Nieto R, Soonawalla Z, White S, Sergeant G, Coolsen MME, Kuemmerli C, Scuderi V, Berrevoet F, Vanlander A, Marudanayagam R, Tanis PJ, Dewulf MJL, Fichtinger RS, Eminton ZB, Neumann UP, Brandts L, Pugh SA, Fretland AA, Primrose JN, van Dam RM; ORANGE II PLUS Collaborative. Healthcare Utilization, Costs, and Cost-Effectiveness of Patients Undergoing Laparoscopic and Open Hemihepatectomy: A Secondary Analysis of the ORANGE II PLUS Randomized Controlled, Phase 3, Superiority Trial. Ann Surg Oncol. 2026 Apr;33(4):2882-2898. doi: 10.1245/s10434-025-18779-4. Epub 2025 Dec 12.
- Derived from this study: PubMed 40491830Olij B, Fichtinger RS, Aldrighetti LA, Abu Hilal M, Troisi RI, Sutcliffe RP, Besselink MG, Aroori S, Menon KV, Edwin B, D'Hondt M, Lucidi V, Ulmer TF, Diaz-Nieto R, Soonawalla Z, White S, Sergeant G, Ratti F, Kuemmerli C, Scuderi V, Berrevoet F, Vanlander A, Marudanayagam R, Tanis PJ, Dewulf MJL, Eminton ZB, Neumann UP, Brandts L, Pugh SA, Fretland AA, Kimman ML, Primrose JN, van Dam RM; ORANGE II PLUS Collaborative. Health-related quality of life in patients undergoing laparoscopic versus open hemihepatectomy: a secondary analysis of the ORANGE II PLUS randomised controlled, phase 3, superiority trial. Lancet Reg Health Eur. 2025 May 19;54:101311. doi: 10.1016/j.lanepe.2025.101311. eCollection 2025 Jul.
- Derived from this study: PubMed 38640453Fichtinger RS, Aldrighetti LA, Abu Hilal M, Troisi RI, Sutcliffe RP, Besselink MG, Aroori S, Menon KV, Edwin B, D'Hondt M, Lucidi V, Ulmer TF, Diaz-Nieto R, Soonawalla Z, White S, Sergeant G, Olij B, Ratti F, Kuemmerli C, Scuderi V, Berrevoet F, Vanlander A, Marudanayagam R, Tanis P, Dewulf MJL, Dejong CHC, Eminton Z, Kimman ML, Brandts L, Neumann UP, Fretland AA, Pugh SA, van Breukelen GJP, Primrose JN, van Dam RM; ORANGE II PLUS Collaborative. Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial. J Clin Oncol. 2024 May 20;42(15):1799-1809. doi: 10.1200/JCO.23.01019. Epub 2024 Apr 19.
- Individual participant dataSharing planned: No
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.
R.M. van Dam, MD PhD principal investigator
Maastricht University Medical Center
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open or Laparoscopic left hemihepatectomy and Open or Laparoscopic right hemihepatectomy in people with Liver Lesions Requiring Hemihepatectomy, 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 5 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: finished, as of the sponsor's last update on 18 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, Belgium, Netherlands, Germany, Italy 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT01441856, which also lists 4 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 18 May 2025.