The ORANGE II PLUS - Trial: Open Versus Laparoscopic Hemihepatectomy
This study is not yet open for participant recruitment.
Verified February 2013 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
Collaborators:
Universitaire Ziekenhuizen Leuven
Henri Mondor University Hospital
Oslo University Hospital
University Hospital Southampton NHS Foundation Trust.
Scientific Institute San Raffaele
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01441856
First received: April 27, 2011
Last updated: February 18, 2013
Last verified: February 2013
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Purpose
The added value of the laparoscopic hemihepatectomy compared to the open hemihepatectomy has never been studied in a randomised controlled setting. Therefore, the multicentre 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, total morbidity (intraoperative incidents and postoperative complications), composite of liver specific morbidity, quality of life, body image and cosmesis, 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 |
|---|---|
|
Laparoscopic 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: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | The ORANGE II PLUS - Trial: an International Multicentre Randomised Controlled Trial of Open Versus Laparoscopic Hemihepatectomies. |
Resource links provided by NLM:
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: | February 2013 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2015 (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 an open left hemihepatectomy within an enhanced recover programme.
|
|
Active Comparator: Open or Laparoscopic Right
Open or Laparoscopic right hemihepatectomy
|
Procedure: Open or Laparoscopic right hemihepatectomy
Patients in this arm will undergo an open right hemihepatectomy within an enhanced recover programme.
|
|
Active Comparator: Prospective registry
Prospective registry of patients that cannot be randomized (both open annd laparoscopic left + right hemihepatectomy)
|
Procedure: Open or Laparoscopic left hemihepatectomy
Patients in this arm will undergo an open left hemihepatectomy within an enhanced recover programme.
Procedure: Open or Laparoscopic right hemihepatectomy
Patients in this arm will undergo an open right hemihepatectomy within an enhanced recover programme.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients requiring open or laparoscopic left / right hemihepatectomy for accepted indications
- Able to understand the nature of the study and what will be required of the
- Men and non-pregnant, non-lactating women between age 18-80
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441856
Contacts
| Contact: Ronald M. van Dam, MD | +31 43 387 74 89 | r.vandam@mumc.nl |
| Contact: Cornelis C.H. Dejong, MD / PhD / Professor | +31 43 387 65 43 | chc.dejong@mumc.nl |
Locations
| Netherlands | |
| Maastricht University Medical Centre | Not yet recruiting |
| Maastricht, Limburg, Netherlands, 6202 AZ | |
Sponsors and Collaborators
Maastricht University Medical Center
Universitaire Ziekenhuizen Leuven
Henri Mondor University Hospital
Oslo University Hospital
University Hospital Southampton NHS Foundation Trust.
Scientific Institute San Raffaele
Investigators
| Study Director: | Cornelis H.C. Dejong, Professor | Maastricht University Medical Centre |
| Principal Investigator: | Ronald M. van Dam, Drs. | Maastricht University Medical Centre |
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: | February 18, 2013 |
| 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 May 22, 2013