The ORANGE II PLUS - Trial: Open Versus Laparoscopic Hemihepatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Maastricht University Medical Center
Sponsor:
Collaborators:
University Hospital Southampton NHS Foundation Trust.
University Hospital, Ghent
San Raffaele University Hospital, Italy
Plymouth Hospitals NHS Trust
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital Birmingham
King's College Hospital NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Royal Free Hospital NHS Foundation Trust
Oslo University Hospital
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01441856
First received: April 27, 2011
Last updated: September 22, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention
Liver Lesions Requiring Hemihepatectomy
Procedure: Open or Laparoscopic left hemihepatectomy
Procedure: Open or Laparoscopic right hemihepatectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The ORANGE II PLUS - Trial: an International Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Hemihepatectomies.

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Time to functional recovery [ Time Frame: expected average of 4-10 days ] [ Designated as safety issue: No ]
    Time until a patient is functionally recovered


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Total length of hospital stay

  • Readmission percentage [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Total percentage of patients being readmitted

  • Total morbidity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Total morbidity during one year

  • Composite endpoint of liver specific morbidity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Composite endpoint of liver specific morbidity(intra-abdominal bleeding, intra-abdominal abcess, ascites, postresectional liver failure, intra-operative mortality, bile leakage)

  • Long term incidence of incisional hernia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Incidence of incisional hernia after 1 year

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    QoL assessment (QLQ-C30 + LM 21) during one year

  • Body image and cosmesis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Influence of intervention on body image and cosmesis during one year

  • Reasons for delay in discharge after functional recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Intraoperative blood loss [ Time Frame: During procedure ] [ Designated as safety issue: No ]
  • Intraoperative time [ Time Frame: Surgical time from incision to closure ] [ Designated as safety issue: No ]
  • Resection margin [ Time Frame: During pathology assessment ] [ Designated as safety issue: No ]
  • Time to adjuvant chemotherapy initiation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Hospital and societal cost [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 5-year overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: October 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open or Laparocopic Left
Open or Laparoscopic left hemihepatectomy
Procedure: Open or Laparoscopic left hemihepatectomy
Patients in this arm will undergo a left hemihepatectomy within an Enhanced Recovery After Surgery Program.
Active Comparator: Open or Laparoscopic Right
Open or Laparoscopic right hemihepatectomy
Procedure: Open or Laparoscopic right hemihepatectomy
Patients in this arm will undergo a right hemihepatectomy within an Enhanced Recovery After Surgery Program.
Active Comparator: Prospective registry
Prospective registry of patients that cannot be randomized (both open and laparoscopic left + right hemihepatectomy)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441856

Contacts
Contact: R. M. van Dam, MD PhD +31 43 387 74 89 r.vandam@mumc.nl
Contact: C. H. Dejong, Prof. +31 43 387 65 43 chc.dejong@mumc.nl

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium
Contact: R. I. Troisi, Prof.         
Principal Investigator: R. I. Troisi, Prof.         
Sub-Investigator: V. Scuderi, MD         
Italy
San Raffaele Hospital Recruiting
Milan, Italy
Contact: L. Aldrighetti, Prof.         
Principal Investigator: L. Aldrighetti, Prof.         
Sub-Investigator: F. Ratti, MD PhD         
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: M. G. Besselink, MD PhD         
Principal Investigator: M. G. Besselink, MD PhD         
Sub-Investigator: P. J. Tanis, MD PhD         
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: C. H. Dejong, Prof.         
Principal Investigator: R.M. van Dam, MD PhD         
Sub-Investigator: R.S. Fichtinger, MD         
Sub-Investigator: M. Klinkert, MD         
Norway
University Hospital Recruiting
Oslo, Norway
Contact: B. E. Edwin, Prof.         
Principal Investigator: B. E. Edwin, Prof.         
Sub-Investigator: Å A. Fretland, MD PhD         
United Kingdom
University Hospital Birmingham Recruiting
Birmingham, United Kingdom
Contact: R. Sutcliffe, MD PhD         
Principal Investigator: R. Sutcliffe, MD PhD         
Sub-Investigator: P. Marudanayagam, MD PhD         
Sub-Investigator: D. Bennett, MD PhD         
King's College Hospital Recruiting
London, United Kingdom
Contact: K. V. Menon, MD PhD         
Principal Investigator: K. V. Menon, MD PhD         
Sub-Investigator: A. Ayers, MD PhD         
Royal Free Hospital NHS Foundation Trust Active, not recruiting
London, United Kingdom
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: S. A. White, Prof.         
Principal Investigator: S. A. White, Prof.         
Sub-Investigator: S. M. Robinson, MD PhD         
Derriford Hospital Recruiting
Plymouth, United Kingdom
Contact: S. Aroori, MD PhD         
Principal Investigator: S. Aroori, MD PhD         
Sub-Investigator: C. Briggs, MD PhD         
University Hospital Southampton Recruiting
Southampton, United Kingdom
Contact: J. N. Primrose, Prof.         
Principal Investigator: M. Abu Hilal, MD PhD         
Sub-Investigator: A. S. Takhar, MD PhD         
Sub-Investigator: T. H. Armstrong, MD PhD         
Sub-Investigator: Z. R. Hamady, MD PhD         
Sponsors and Collaborators
Maastricht University Medical Center
University Hospital Southampton NHS Foundation Trust.
University Hospital, Ghent
San Raffaele University Hospital, Italy
Plymouth Hospitals NHS Trust
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital Birmingham
King's College Hospital NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Royal Free Hospital NHS Foundation Trust
Oslo University Hospital
Investigators
Study Director: C. H. Dejong, Prof. Maastricht University Medical Center
Principal Investigator: R. M. van Dam, MD PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01441856     History of Changes
Other Study ID Numbers: NL36215.068.11 
Study First Received: April 27, 2011
Last Updated: September 22, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Open
Laparoscopic
Hemihepatectomy
Enhanced Recovery After Surgery
Functional recovery

ClinicalTrials.gov processed this record on February 09, 2016