The ORANGE II PLUS - Trial: Open Versus Laparoscopic Hemihepatectomy

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.

Conditions

• Liver Lesions Requiring Hemihepatectomy

Interventions

PROCEDURE

Open or Laparoscopic left hemihepatectomy

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

PROCEDURE

Open or Laparoscopic right hemihepatectomy

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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• Derriford Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Queen Elizabeth Hospital NHS Foundation Trust

  collaborator OTHER

• King's College London

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• General Hospital Groeninge

  collaborator OTHER

• Jessa Hospital

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• University Hospital, Aachen

  collaborator OTHER

• Liverpool University Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• R.M. van Dam, MD PhD · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-01

Primary Completion

2019-12-04

Completion

2023-12-04

Countries

• Belgium
• Germany
• Italy
• Netherlands
• Norway
• United Kingdom

Study Locations