ClinicalTrials.gov
ClinicalTrials.gov Menu

The ORANGE II PLUS - Trial: Open Versus Laparoscopic Hemihepatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01441856
Recruitment Status : Active, not recruiting
First Posted : September 28, 2011
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
University 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
Aintree University Hospitals NHS Foundation Trust
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Lesions Requiring Hemihepatectomy Procedure: Open or Laparoscopic left hemihepatectomy Procedure: Open or Laparoscopic right hemihepatectomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: The patient, surgical ward physician and surgical ward nurses are blinded up and until postoperative day 4.
Primary Purpose: Treatment
Official Title: The ORANGE II PLUS - Trial: an International Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Hemihepatectomies.
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : December 4, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Time to functional recovery [ Time Frame: expected average of 4-10 days ]
    Time until a patient is functionally recovered


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 30 days ]
    Total length of hospital stay

  2. Readmission percentage [ Time Frame: 1 year ]
    Total percentage of patients being readmitted

  3. Total morbidity [ Time Frame: 1 year ]
    Total morbidity during one year

  4. Composite endpoint of liver specific morbidity [ Time Frame: 1 year ]
    Composite endpoint of liver specific morbidity(intra-abdominal bleeding, intra-abdominal abcess, ascites, postresectional liver failure, intra-operative mortality, bile leakage)

  5. Long term incidence of incisional hernia [ Time Frame: 1 year ]
    Incidence of incisional hernia after 1 year

  6. Quality of life: QLQ-C30 + LM 21 [ Time Frame: 1 year ]
    Quality of life assessment (QLQ-C30 + LM 21) during one year

  7. Body image and cosmesis [ Time Frame: 1 year ]
    Influence of intervention on body image and cosmesis during one year

  8. Reasons for delay in discharge after functional recovery [ Time Frame: 1 year ]
  9. Intraoperative blood loss [ Time Frame: During procedure ]
  10. Intraoperative time [ Time Frame: Surgical time from incision to closure ]
  11. Resection margin [ Time Frame: During pathology assessment ]
  12. Time to adjuvant chemotherapy initiation [ Time Frame: 1 year ]
  13. Hospital and societal cost [ Time Frame: 1 year ]
  14. 5-year overall survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441856


Locations
Belgium
Erasmus Hospital
Brussels, Belgium
Ghent University Hospital
Ghent, Belgium
Jessa Hospital
Hasselt, Belgium
General Hospital Groeninge
Kortrijk, Belgium
Germany
University Hospital Aachen
Aachen, Germany
Italy
San Raffaele Hospital
Milan, Italy
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Maastricht University Medical Center+
Maastricht, Netherlands
Norway
University Hospital Oslo
Oslo, Norway
United Kingdom
Aintree University Hospital
Aintree, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
King's College Hospital
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Oxford University Hospitals
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Sponsors and Collaborators
Maastricht University Medical Center
University 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
Aintree University Hospitals NHS Foundation Trust
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: R.M. van Dam, MD PhD Maastricht University Medical Center

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01441856     History of Changes
Other Study ID Numbers: NL36215.068.11
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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