Intrahepatic Blood Flow Occlusion and Cardiac Injury Risk in Partial Hepatectomy

NCT ID: NCT06753461

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-28

Study Completion Date

2024-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perioperative Myocardial Injury Myocardial Injury After Non-Cardiac Surgery Hypotension Ischemia Reperfusion Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Occlusion

During the entire operation, no blood flow to the liver was occluded.

No interventions assigned to this group

Portal Vein Occlusion

During the entire procedure, only the portal vein was occluded.

intrahepatic blood flow occlusion

Intervention Type PROCEDURE

The specified blood vessel is temporarily clamped to achieve the intended blockage of blood flow.

Pringle Occlusion

Pringle occlusion was performed throughout the operation.

intrahepatic blood flow occlusion

Intervention Type PROCEDURE

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.

intrahepatic blood flow occlusion

Intervention Type PROCEDURE

The specified blood vessel is temporarily clamped to achieve the intended blockage of blood flow.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intrahepatic blood flow occlusion

The specified blood vessel is temporarily clamped to achieve the intended blockage of blood flow.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhifeng Gao

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24446-4-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Remote Ischemic Postconditioning
NCT01450475 COMPLETED PHASE1