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Effect of Intermittent Hepatic Inflow Occlusion During Donor Hepatectomy In Living Donor Liver Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Samsung Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01171742
First Posted: July 28, 2010
Last Update Posted: July 28, 2010
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.
Information provided by:
Samsung Medical Center
  Purpose
Intermittent hepatic inflow occlusion (IHIO), also called Pringle maneuver, is a safe and effective procedure for major hepatectomy in patients with liver disease. In addition, ischemic preconditioning with IHIO has been reported to have protective effects in patients undergoing liver resection. The role of IHIO, however, has not been fully elucidated in donors and recipients during living donor liver transplantation.

Condition Intervention Phase
End Stage Liver Disease Living Donor Procedure: Intermittent hepatic inflow occlusion (IHIO) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intermittent Hepatic Inflow Occlusion During Donor Hepatectomy In Adult Living Donor Liver Transplantation Using Right Hemiliver Grafts

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Serum alanine aminotransferase (ALT) concentration within 5 days post-operative [ Time Frame: pre-operative and every day till 5 days post-operative ]
    The primary end-point of this study is peak serum alanine aminotransferase (ALT) concentration within 5 days post-operation on donors and recipients.


Secondary Outcome Measures:
  • post-operative clinical courses, such as liver function tests, hospital stay, and morbidity [ Time Frame: During post-operative 1 months or hospitalization ]
    Secondary end-points in recipients include those involving post-operative clinical courses, such as liver function tests, graft function, stay in the intensive care unit and in-hospital mortality, hospital stay and in donors post-operative clinical courses, such as liver function tests, hospital stay and morbidity requiring additional interveition or delay of hospital stay.

  • Serum interleukin (IL)-6, IL-8, tumor necrosis factor (TNF)- α, and hepatocyte growth factor (HGF) [ Time Frame: In donors immediately after anesthesia induction and 2 hours after graft removal, and in recipients immediately after anesthesia induction, during the anhepatic phase, 2 hours after reperfusion, and at 1 and 3 days post-operatively. ]
    Blood samples for measurement of interleukin (IL)-6, IL-8, tumor necrosis factor (TNF)- α, and hepatocyte growth factor (HGF) will be taken from donors immediately after anesthesia induction and 2 hours after graft removal, and from recipients immediately after anesthesia induction, during the anhepatic phase, 2 hours after reperfusion, and at 1 and 3 days post-operatively.

  • Caspase-3 and malondialdehyde in liver biopsy [ Time Frame: In donors at the time of laparotomy, just before portal vein and hepatic artery clamping after parenchymal resection, and in recipients two hours after reperfusion ]
    Biopsy samples'll be taken from donors at the time of laparotomy, just before portal vein and hepatic artery clamping after parenchymal resection, and from recipients two hours after reperfusion. Hepatocyte injury will be determined by measuring the concentrations of caspase-3, and malondialdehyde (MDA) by ELISA.


Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IHIO
Intermittent hepatic inflow occlusion (IHIO) by clamping of the portal triad, minimizes blood loss and operation time during liver resection. In addition, ischemic preconditioning with IHIO has been reported to have protective effects in patients undergoing liver resection. IHIO'll be usually performed 3 times during donor liver parenchymal resection, with each IHIO consisting of clamping of the hepatoduodenal ligament for 15 minutes, followed by reperfusion for 5 minutes.
Procedure: Intermittent hepatic inflow occlusion (IHIO)
Intermittent hepatic inflow occlusion (IHIO)'ll be usually performed 3 times during donor liver parenchymal resection, with each IHIO consisting of clamping of the hepatoduodenal ligament for 15 minutes, followed by reperfusion for 5 minutes.
Sham Comparator: Control
The donor liver parenchyma'll be transected without IHIO.
Procedure: Intermittent hepatic inflow occlusion (IHIO)
Intermittent hepatic inflow occlusion (IHIO)'ll be usually performed 3 times during donor liver parenchymal resection, with each IHIO consisting of clamping of the hepatoduodenal ligament for 15 minutes, followed by reperfusion for 5 minutes.

Detailed Description:
Intermittent hepatic inflow occlusion (IHIO) by clamping of the portal triad, also called Pringle maneuver, is a safe and effective procedure in major hepatectomy in patients with liver disease. IHIO minimizes blood loss and operation time during liver resection. In addition, ischemic preconditioning with IHIO has been reported to have protective effects in patients undergoing liver resection. In the setting of living donor liver transplantation (LDLT), one of the most important concerns is liver donor safety. Several studies have shown the safety of IHIO in donors for liver transplantation (LT). However, the effect of preconditioning with IHIO during donor hepatectomy on LDLT recipients remains unclear. Several small series have assessed the effects on recipients of ischemic preconditioning during whole liver transplantation from deceased donors. The role of IHIO, however, has not been fully elucidated in liver donors and recipients during LDLT. In this randomized, prospective study, we'll evaluate the efficacy of IHIO in the recipients and donors.
  Eligibility

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
Criteria

Inclusion Criteria:

  • Donors and recipient of LDLT, saged ≥18 years, who will undergo LDLT with donors undergoing right hemihepatectomy and recipients receiving right hemiliver grafts
  • Informed consent agreement

Exclusion Criteria:

  • if the recipients has fulminant hepatic failure
  • if the graft to recipient body weight ratio (GRWR) is <0.9
  • if a frozen biopsy of the donor liver taken prior to donor hemihepatectomy shows >30% macrovesicular steatosis
  • if liver transplantation is ABO incompatible
  • if recipients has received previous organ transplants
  • if recipients has received or were scheduled to receive multi-organ transplants
  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): NCT01171742


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jae-Won Joh, MD., PhD Samsung Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samsung Medical Center, JAE WON JOH
ClinicalTrials.gov Identifier: NCT01171742     History of Changes
Other Study ID Numbers: 2007-09-096
First Submitted: July 27, 2010
First Posted: July 28, 2010
Last Update Posted: July 28, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency


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