CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 350 enrolled
Drug / intervention
Open or Laparoscopic left hemihepatectomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01441856
NCT01441856N/ACompleted
CompareCT.gov

The ORANGE II PLUS - Trial: an International Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Hemihepatectomies.

Maastricht University Medical Center·interventional·Posted Sep 28, 2011·Updated May 18, 2025

In Brief

A clinical study evaluating Open or Laparoscopic left hemihepatectomy and Open or Laparoscopic right hemihepatectomy for Liver Lesions Requiring Hemihepatectomy. Completed, enrolled 350 participants across 16 sites in 6 countries.

Detailed 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 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Lesions Requiring Hemihepatectomy
CountriesBelgium, Germany, Italy, Netherlands, Norway, United Kingdom
CollaboratorsUniversity 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

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2011
Enrollment StartOct 1, 2013
Primary CompletionDec 4, 2019
Study CompletionDec 4, 2023
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 14.8 years ago

Interventions

Open or Laparoscopic left hemihepatectomyprocedure

Patients in this arm will undergo a left hemihepatectomy within an Enhanced Recovery After Surgery Program.

Open or Laparoscopic right hemihepatectomyprocedure

Patients in this arm will undergo a right hemihepatectomy within an Enhanced Recovery After Surgery Program.