Orange II Plus Trial

Title

Orange II Plus trial – an international multicentre randomised controlled trial comparing open and laparoscopic hemihepatectomy within an enhanced recovery (ERAS) programme.

Description

A prospective randomised two arm study to determine the benefits of laparoscopic (keyhole) surgery over conventional open surgery in patients undergoing a hemihepatectomy and participating in an enhanced recovery (ERAS) programme in terms of time to functional recovery.

Objectives

The ORANGE II PLUS - Trial aims to provide evidence on the merits of laparoscopic surgery in two separate patient populations: either patients undergoing hemihepatectomy or patients having parenchymal sparing resection of the postero-superior liver segments.

Primary endpoint:

• Time to functional recovery.

Secondary endpoints:

• Length of stay in hospital (LOS), intraoperative blood loss, operation time, resection margin, time to adjuvant chemotherapy initiation, readmission percentage, (liver specific) morbidity, quality of life (QOL), body image, reasons for delay of discharge after functional recovery, long term incidence of incisional hernias, hospital and societal costs during one year, overall five-year survival.

Trial Design

The international multicentre ORANGE II PLUS - Trial is a prospective, double blinded, randomized controlled study of two separate and independent patient populations, each producing two arms (open versus laparoscopy) with a parallel registry. These populations involve patients undergoing left or right hemihepatectomy and patients having parenchymal preserving resection of one or two postero-superior liver segments
(involving one or two of segments 4a, 7 or 8).

Trial Status

Open to recruitment.

Population

All patients - 18 years and older - with anatomic benign and/or malignant lesions requiring a hemihepatectomy with or without the need for one additional hepatic wedge resection or metastasectomy, or patients in need for a parenchymal sparing resection of postero-superior liver segments (involving one or two of segments 4a, 7, 8) that the multidisciplinary team feel is technically feasible and safe by either the laparoscopic or open approach.

Considerations

Research will be conducted in UK centres that are capable of performing specialist laparascopic surgery. It will be a single-blinded study so that the patient remains unaware of which surgical procedure has been conducted. Where possible the patient and post-operative staff will remain blinded until post-operative day 4 (POD4).

This trial is funded by Cancer Research Uk (award reference no. C317/A16248)