Intrahepatic Blood Flow Occlusion and Cardiac Injury Risk in Partial Hepatectomy

Completed

• Conditions: Perioperative Myocardial Injury; Myocardial Injury After Non-Cardiac Surgery; Hypotension; Ischemia Reperfusion Injury

• Registration Number: NCT06753461
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

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

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 Timeline

• Study Start: 2014-11-28
• Primary Completion: 2024-05-20
• Study Completion: 2024-11-20
• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2024-12-21
• Study First Posted: 2024-12-31
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial injury after non-cardiac surgery (MINS)	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