Intrahepatic Blood Flow Occlusion and Cardiac Injury Risk in Partial Hepatectomy

February 19, 2025 updated by: Zhifeng Gao, Beijing Tsinghua Chang Gung Hospital

Intrahepatic Blood Flow Occlusion Strategies and Postoperative Cardiac Injury Risk in Partial Hepatectomy: a Ten-Year Retrospective Study

The goal of this observational study is to examine whether intrahepatic blood flow occlusion strategies during partial hepatectomy are associated with postoperative cardiac injury in patients undergoing hepatectomy. The primary questions it seeks to address are:

  1. Are the intrahepatic blood flow occlusion method, the number of occlusions, and the cumulative occlusion time associated with postoperative cardiac injury?
  2. How do intrahepatic blood flow occlusion, intraoperative hypotension, and postoperative cardiac injury interact? Participants will contribute their inpatient medical records, including information on medical history, surgical procedures, and anesthesia details.

Study Overview

Detailed Description

Liver resection is currently the primary surgical treatment for liver tumors, injuries, and other diseases. With the continuous development of surgical techniques, its application has been expanding. However, intraoperative bleeding and poor surgical field exposure remain major challenges in liver resection, seriously affecting the safety and efficacy of the operation.

Hepatic inflow occlusion is a commonly used technique to address these challenges. It can effectively reduce intraoperative bleeding and improve surgical field exposure. However, it can also lead to hepatic ischemia-reperfusion injury, which may aggravate the damage to the remnant liver and even affect liver regeneration.

Recent studies suggest that hepatic ischemia-reperfusion injury may affect distant organs such as the kidneys, brain, lungs, and heart. However, there is still insufficient clinical evidence, especially regarding myocardial injury. In addition, intraoperative hypotension is a common complication of liver resection and may exacerbate the impact of ischemia-reperfusion injury on the myocardium.

This study intends to construct a model incorporating variables related to intraoperative hepatic ischemia and reperfusion, and analyze the relationship between hepatic inflow occlusion and postoperative myocardial injury in liver resection using logistic regression, while considering the mediating effect of hypotension. The results of this study will provide important clinical evidence for optimizing liver resection strategies, reducing myocardial injury, and improving patient prognosis. This research holds significant scientific and clinical value, and is expected to improve the quality of liver surgery and patient survival rates.

Study Type

Observational

Enrollment (Actual)

2600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients aged ≥18 years who underwent partial hepatectomy.

Description

Inclusion Criteria:

Hospitalized patients aged ≥18 years who underwent partial hepatectomy between November 28, 2004, and May 20, 2024.

Exclusion Criteria:

  1. End-stage renal disease patients (requiring renal replacement therapy)
  2. ASA score ≥ 4
  3. Lack of intraoperative hepatic portal occlusion data
  4. Insufficient perioperative myocardial injury biomarker measurement data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Occlusion
During the entire operation, no blood flow to the liver was occluded.
Portal Vein Occlusion
During the entire procedure, only the portal vein was occluded.
The specified blood vessel is temporarily clamped to achieve the intended blockage of blood flow.
Pringle Occlusion
Pringle occlusion was performed throughout the operation.
The specified blood vessel is temporarily clamped to achieve the intended blockage of blood flow.
Both Occlusion
Both Pringle occlusion and portal vein block were performed throughout the procedure.
The specified blood vessel is temporarily clamped to achieve the intended blockage of blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial injury after non-cardiac surgery (MINS)
Time Frame: Within 3 days after sugery
a high-sensitivity troponin T (hs-TnT) of 20 to <65 ng/L with an absolute change of at least 5 ng/L
Within 3 days after sugery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2014

Primary Completion (Actual)

May 20, 2024

Study Completion (Actual)

November 20, 2024

Study Registration Dates

First Submitted

December 21, 2024

First Submitted That Met QC Criteria

December 21, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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