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NCT01441856
The ORANGE II PLUS - Trial: Open Versus Laparoscopic Hemihepatectomy
NA trial testing Open or Laparoscopic left hemihepatectomy in Liver Lesions Requiring Hemihepatectomy in 350 participants. Completed in 4 December 2023.
4 December 2019
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 350 |
| Start date | 1 October 2013 |
| Primary completion | 4 December 2019 |
| Estimated completion | 4 December 2023 |
| Sites | 16 locations across Italy, Netherlands, Belgium, United Kingdom, Germany, Norway |
Drugs / interventions tested
- Open or Laparoscopic left hemihepatectomy
- Open or Laparoscopic right hemihepatectomy
Conditions studied
- Liver Lesions Requiring Hemihepatectomy — all drugs for Liver Lesions Requiring Hemihepatectomy →
Sponsor
Maastricht University Medical Center
Who can join
18 and older, any sex, with Liver Lesions Requiring Hemihepatectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial.
Fichtinger RS, Aldrighetti LA, Abu Hilal M, Troisi RI, et al · · 2024 · cited 55× · PMID 38640453 · DOI 10.1200/jco.23.01019 -
Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial.
Fretland ÅA, Kazaryan AM, Bjørnbeth BA, Flatmark K, et al · · 2015 · cited 52× · PMID 25872027 · DOI 10.1186/s13063-015-0577-5 -
Laparoscopic versus open liver resection for benign and malignant hepatic lesions in adults.
Rao AM, Ahmed I. · · 2013 · cited 27× · PMID 23728700 · DOI 10.1002/14651858.cd010162.pub2 -
Laparoscopic hepatectomy versus open hepatectomy for colorectal cancer liver metastases: comparative study with propensity score matching.
Untereiner X, Cagniet A, Memeo R, Tzedakis S, et al · · 2016 · cited 17× · PMID 27500141 · DOI 10.21037/hbsn.2015.12.06 -
Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial.
Kuemmerli C, Fichtinger RS, Moekotte A, Aldrighetti LA, et al · · 2022 · cited 11× · PMID 35264216 · DOI 10.1186/s13063-022-06112-3 -
Short-term outcomes of open liver resection and laparoscopic liver resection: Secondary analysis of data from a multicenter prospective study (CSGO-HBP-004).
Kobayashi S, Fukui K, Takeda Y, Nakahira S, et al · · 2018 · cited 11× · PMID 29863161 · DOI 10.1002/ags3.12046 -
Comparative Effectiveness of Minimally Invasive Surgery and Conventional Approaches for Major or Challenging Hepatectomy.
Thornblade LW, Shi X, Ruiz A, Flum DR, et al · · 2017 · cited 11× · PMID 28163089 · DOI 10.1016/j.jamcollsurg.2017.01.051 -
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.
Olij B, Fichtinger RS, Aldrighetti LA, Abu Hilal M, et al · · 2025 · cited 3× · PMID 40491830 · DOI 10.1016/j.lanepe.2025.101311
Verify or expand the search:
- PubMed search for NCT01441856
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01441856 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 18 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01441856.
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