- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06753461
Intrahepatic Blood Flow Occlusion and Cardiac Injury Risk in Partial Hepatectomy
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:
- Are the intrahepatic blood flow occlusion method, the number of occlusions, and the cumulative occlusion time associated with postoperative cardiac injury?
- 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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Hospitalized patients aged ≥18 years who underwent partial hepatectomy between November 28, 2004, and May 20, 2024.
Exclusion Criteria:
- End-stage renal disease patients (requiring renal replacement therapy)
- ASA score ≥ 4
- Lack of intraoperative hepatic portal occlusion data
- Insufficient perioperative myocardial injury biomarker measurement data
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24446-4-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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