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

NCT01171742 | Unknown Phase 3 DMC

• 1 other identifier: 2007-09-096
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Liver Disease; Living Donor

Outcome Measures

Primary Outcomes (1)

• Serum alanine aminotransferase (ALT) concentration within 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.

  pre-operative and every day till 5 days post-operative

Secondary Outcomes (3)

• post-operative clinical courses, such as liver function tests, hospital stay, and morbidity

  During post-operative 1 months or hospitalization

• Serum interleukin (IL)-6, IL-8, tumor necrosis factor (TNF)- α, and hepatocyte growth factor (HGF)

  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.

• Caspase-3 and malondialdehyde in liver biopsy

  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

Study Arms (2)

IHIO

EXPERIMENTAL

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)

Control

SHAM COMPARATOR

The donor liver parenchyma'll be transected without IHIO.

Procedure: Intermittent hepatic inflow occlusion (IHIO)

Interventions

Intermittent hepatic inflow occlusion (IHIO) PROCEDURE

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.

Control; IHIO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Park JB, Joh JW, Kim SJ, Kwon CH, Chun JM, Kim JM, Moon JI, Lee SK. Effect of intermittent hepatic inflow occlusion with the Pringle maneuver during donor hepatectomy in adult living donor liver transplantation with right hemiliver grafts: a prospective, randomized controlled study. Liver Transpl. 2012 Jan;18(1):129-37. doi: 10.1002/lt.22409.

  PMID: 21837746 DERIVED

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Jae-Won Joh, MD., PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 28, 2010

Record last verified: 2010-07

Locations

KR (1)