Hypothermic Perfusion During Hemihepatectomy

Not Applicable

Completed

• Conditions: Hepatic Ischemia-reperfusion Injury
• Interventions: Procedure: In situ hypothermic perfusion

• Registration Number: NCT01499979
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

Rationale

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.

Objective

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).

Intervention

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-23
• Study First Posted: 2011-12-26
• Study Start: 2012-02
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypothermic perfusion	In situ hypothermic perfusion	Patients will receive in situ hypothermic perfusion of the future remnant liver during liver resection.

Primary Outcome Measures

Name	Time	Method
Postoperative hepatocellular damage	5 days postoperatively	Hepatocellular damage expressed as an postoperative increase in transaminases (i.e., AST and ALT).

Secondary Outcome Measures

Name	Time	Method
Regeneration of liver function and volume	3 days	Regeneration of liver function (measured via hepatobiliary scintigraphy) and -volume (measured via CT volumetry).
Intraoperative blood loss	2-3 hours	Blood loss during surgery
Postoperative complications	5 days postoperatively	Incidence of surgery-related complications

Trial Locations

Locations (1)

Academic Medical Center (AMC); 🇳🇱 Amsterdam, Noord-Holland, Netherlands