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Hypothermic Perfusion During Hemihepatectomy

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ClinicalTrials.gov Identifier: NCT01499979
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : January 26, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:


Currently, hepatic resection is often the only curative treatment for primary or secondary hepatic malignancies and is also frequently performed in patients with benign liver tumors to prevent malignant transformation and/or alleviate symptoms. Liver resections are nowadays associated with low mortality and acceptable morbidity. As result of that, an increasing number of patients is currently under consideration for resection of more complex or large tumors, thus requiring extensive resection procedures. Application of vascular exclusion (i.e., clamping of the portal vein and hepatic artery) during such procedures reduces blood loss, which is one of the most important factors affecting peri-operative outcomes. However, vascular exclusion leads to ischemia-reperfusion (I/R) injury as an inevitable side-effect, which adversely impacts postoperative liver function and regeneration. Additional cooling of the liver by means of hypothermic perfusion is expected to further reduce intraoperative blood loss, as well as to protect the liver from I/R injury. Therefore, the aim of this pilot study is to cool the future remnant liver (FRL) in situ during right hemihepatectomy under vascular exclusion. Consequently, an overall improvement in postoperative outcomes is expected due to a decrease in intraoperative blood loss, reduced parenchymal damage, and a better ability of the liver remnant to regenerate.


To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion with retrograde outflow (R-IHP) of the FRL.

Study design

The study is designed as a prospective randomized pilot study in 18 patients (9 interventions and 9 controls) to assess the effects of the proposed intervention. Additionally, 4 patients will be included separately for assessment of the intervention's feasibility prior to randomized inclusion.

Study population

Eligible patients for participation in this study are those planned to undergo right hemihepatectomy under vascular inflow occlusion because of a malignant or benign liver tumor, and who do not suffer from any hepatic co-morbidity that might influence postoperative outcomes (i.e., severe steatosis, cholestasis, cirrhosis, or hepatitis B/C infection).


During right hemihepatectomy, the FRL of patients allocated to the intervention group will be perfused with a chilled perfusion solution (i.e., lactated Ringer's solution).

Condition or disease Intervention/treatment
Hepatic Ischemia-reperfusion Injury Procedure: In situ hypothermic perfusion

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: In Situ Hypothermic Perfusion During Right Hemihepatectomy
Study Start Date : February 2012
Primary Completion Date : May 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Vascular inflow occlusion
Patients that will receive intermittent vascular inflow occlusion, the standard method for vascular occlusion at our institution, during liver resection.
Experimental: Hypothermic perfusion
Patients will receive in situ hypothermic perfusion of the future remnant liver during liver resection.
Procedure: In situ hypothermic perfusion
In situ perfusion of the future remnant liver with chilled lactated Ringer's solution during liver resection.
Other Name: In situ hypothermic preservation

Outcome Measures

Primary Outcome Measures :
  1. Postoperative hepatocellular damage [ Time Frame: 5 days postoperatively ]
    Hepatocellular damage expressed as an postoperative increase in transaminases (i.e., AST and ALT).

Secondary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: 2-3 hours ]
    Blood loss during surgery

  2. Postoperative complications [ Time Frame: 5 days postoperatively ]
    Incidence of surgery-related complications

  3. Regeneration of liver function and volume [ Time Frame: 3 days ]
    Regeneration of liver function (measured via hepatobiliary scintigraphy) and -volume (measured via CT volumetry).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for right hemihepatectomy under vascular inflow occlusion for a malignant or benign hepatic tumor
  • Diagnostic exclusion of hepatic co-morbidity, that is:

    • Cirrhosis,
    • Severe steatosis (≥ 30%),
    • Cholestasis, and
    • Hepatitis B/C infection
  • Age ≥ 18 years
  • Signed informed consent obtained prior to any study-specific procedure
  • ASA classification I-III

Exclusion Criteria:

  • Patients diagnosed with any of the hepatic co-morbidities listed under point 2 of the inclusion criteria
  • Age < 18 years
  • BMI > 35 kg/m2
  • ASA classification IV/V
  • Patient is scheduled for a combined surgical procedure (e.g., bile duct resection, gastrointestinal procedures)
  • Patient underwent liver resection ≤ 1 year prior to scheduled surgery
  • Emergency operations
  • Pregnancy or breast feeding
Contacts and Locations

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): NCT01499979

Academic Medical Center (AMC)
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Chair: Prof. Thomas M. van Gulik, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Megan J. Reiniers, MSc Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Rowan F. van Golen, MSc Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information

Responsible Party: Megan J. Reiniers, PhD student, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01499979     History of Changes
Other Study ID Numbers: 2011_214
NL37241.018.11 ( Other Identifier: Centrale Commissie Mensgebonden Onderzoek (CCMO) )
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Megan J. Reiniers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Ischemia-reperfusion injury
In situ hypothermic perfusion
In situ hypothermic preservation

Additional relevant MeSH terms:
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Body Temperature Changes
Signs and Symptoms