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ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection

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ClinicalTrials.gov Identifier: NCT03270917
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Queen Elizabeth Hospital Birmingham
General Hospital Groeninge
Aintree University Hospitals NHS Foundation Trust
King's College Hospital NHS Trust
San Raffaele University Hospital, Italy
Newcastle-upon-Tyne Hospitals NHS Trust
Oslo University Hospital
Oxford University Hospitals NHS Trust
Derriford Hospital
University Hospital Southampton NHS Foundation Trust
Manchester University NHS Foundation Trust
University Hospital, Aachen
Erasme University Hospital
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

The international and multicentre ORANGE SEGMENTS - Trial is a prospective, double blinded, randomized controlled study comparing patients undergoing parenchymal preserving resection of postero-superior liver segments (involving one or two of segments 4a, 7, 8). All patients will be participating in an enhanced recovery programme.

Primary outcome is time to functional recovery. Secondary study parameters include hospital length of stay, intraoperative blood loss, operation time, liver specific morbidity, readmission percentage, resection margin, 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, time to adjuvant chemotherapy initiation, overall five-year survival.


Condition or disease Intervention/treatment Phase
Liver Surgery Procedure: Parenchymal preserving postero-superior liver segment resection Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomised to either the open or the laparoscopic treatment arm.
Masking: Double (Participant, Investigator)
Masking Description: The patient, ward physician and research investigator are blinded to the treatment intervention. A large abdominal dressing will be used to cover the incision(s) until postoperative day 4. Obviously, the surgeon and anaesthesiology team can not be blinded.
Primary Purpose: Treatment
Official Title: The ORANGE SEGMENTS - Trial: an International Multicentre Randomized Controlled Trial of Open Versus Laparoscopic Parenchymal Preserving Postero-superior Liver Segment Resection
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Open
Open liver surgery
Procedure: Parenchymal preserving postero-superior liver segment resection
Parenchymal preserving liver segment resection of one or two of the postero-superior liver segments (4A, 7 or 8).

Laparoscopy
Laparoscopic liver surgery
Procedure: Parenchymal preserving postero-superior liver segment resection
Parenchymal preserving liver segment resection of one or two of the postero-superior liver segments (4A, 7 or 8).




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. Hospital length of stay [ Time Frame: 30 days ]
    Total length of hospital stay

  2. Intraoperative blood loss [ Time Frame: during procedure ]
    Net intraoperative blood loss

  3. Operating time [ Time Frame: surgical time from incision until closure ]
  4. (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. Readmission percentage [ Time Frame: 1 year ]
    Total percentage of patients being readmitted

  6. Resection margin [ Time Frame: 1 year ]
    Residual tumor cells in resection border

  7. Quality of life [ Time Frame: 1 year ]
    The physical, social and emotional well-being of the patient

  8. Body image and cosmesis [ Time Frame: 1 year ]
    The aesthetic appearance of the scars associated with the operation and its influence on the patient self-view

  9. Reasons for delay of discharge after functional recovery [ Time Frame: 1 year ]
    All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.

  10. Incisional herniation [ Time Frame: 1 year ]
    Cicatricial hernia

  11. Hospital and societal costs [ Time Frame: 1 year ]
    All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.

  12. Time to adjuvant chemotherapy initiation [ Time Frame: 1 year ]
    The time it takes to start adjuvant chemotherapy after the patient has been operated

  13. Overall five-year survival [ Time Frame: 5 years ]
    Five-year survival



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.


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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 a parenchymal sparing liver resection (including wedge resections and full segmentectomies) involving one or two of segments 4a/7/8 for accepted indications . A segment 6/7 resection would also be eligible.
  • Able to understand the nature of the study and what will be required of them.
  • Men and non-pregnant, non-lactating women, aged 18 years and older.
  • BMI between and including 18-35 kg/m2
  • Patients with ASA physical status I-II-III.

Exclusion Criteria:

  • Inability to give (written) informed consent.
  • Patients requiring other liver surgery than a parenchymal sparing resection involving one or two of segments 4a, 7, 8.
  • Patients requiring parenchymal sparing liver resection involving segment 1. This is due to the high level of technical difficulty.
  • Patients with hepatic lesion(s), that are located with insufficient margin from vascular or biliary structures to be operated laparoscopically.
  • Patients with ASA physical status 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): NCT03270917


Contacts
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Contact: Alma Moekotte, MD ‭+447402150695‬ a.l.moekotte@soton.ac.uk
Contact: Zina Eminton +447973551272 z.b.eminton@soton.ac.uk

Locations
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Belgium
Erasmus Hospital Not yet recruiting
Brussels, Belgium
Contact: V. Lucidi, MD PhD         
Principal Investigator: V. Lucidi, MD PhD         
Sub-Investigator: G. Katsanos, MD PhD         
General Hospital Groeninge Recruiting
Kortrijk, Belgium
Contact: M. D'Hondt, MD PhD         
Principal Investigator: M. D'Hondt, MD PhD         
Germany
University Hospital Aachen Not yet recruiting
Aachen, Germany
Contact: U.P. Neumann, Prof.         
Principal Investigator: U.P. Neumann, Prof.         
Sub-Investigator: F. Ulmer, MD PhD         
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         
Maastricht University Medical Center+ Not yet recruiting
Maastricht, Netherlands
Contact: R.M. van Dam, MD PhD         
Principal Investigator: R.M. van Dam, MD PhD         
Norway
University Hospital Oslo Not yet recruiting
Oslo, Norway
Contact: Å.A. Fretland, MD PhD         
Principal Investigator: B.E. Edwin, Prof.         
Sub-Investigator: Å.A. Fretland, MD PhD         
United Kingdom
Aintree University Hospital Recruiting
Aintree, United Kingdom
Contact: v Díaz-Nieto, MD PhD         
Principal Investigator: R. Díaz-Nieto, MD PhD         
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom
Contact: R. Sutcliffe, MD PhD         
Principal Investigator: R. Sutcliffe         
Sub-Investigator: P. Marudanayagam         
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         
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Contact: A.J. Sheen, Prof.         
Principal Investigator: A.J. Sheen, Prof.         
Sub-Investigator: J.J. Pilkington, MD PhD         
Freeman Hospital Not yet recruiting
Newcastle, United Kingdom
Contact: S. White, Prof.         
Principal Investigator: S. White, Prof.         
Sub-Investigator: S. Robinson, MD PhD         
Oxford University Hospitals Not yet recruiting
Oxford, United Kingdom
Contact: Z. Soonawalla, MD PhD         
Principal Investigator: Z. Soonawalla, MD PhD         
Sub-Investigator: M.A. Silva, 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: M. Halls, MD PhD         
Principal Investigator: M. Abu Hilal, Prof.         
Principal Investigator: J. Primrose, Prof.         
Sub-Investigator: M. Halls, MD PhD         
Sub-Investigator: S. Pugh, 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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Queen Elizabeth Hospital Birmingham
General Hospital Groeninge
Aintree University Hospitals NHS Foundation Trust
King's College Hospital NHS Trust
San Raffaele University Hospital, Italy
Newcastle-upon-Tyne Hospitals NHS Trust
Oslo University Hospital
Oxford University Hospitals NHS Trust
Derriford Hospital
University Hospital Southampton NHS Foundation Trust
Manchester University NHS Foundation Trust
University Hospital, Aachen
Erasme University Hospital
Investigators
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Study Chair: Mohammed Abu Hilal, Prof. University Hospital Southampton NHS Foundation Trust
Study Chair: John Primrose, Prof. University Hospital Southampton NHS Foundation Trust

Additional Information:
Publications:
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03270917     History of Changes
Other Study ID Numbers: NL36215.068.11*
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maastricht University Medical Center:
Parenchymal preserving
Postero-superior
Laparoscopy
Hepatectomy

Additional relevant MeSH terms:
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Liver Extracts
Hematinics