Intrahepatic Blood Flow Occlusion and Cardiac Injury Risk in Partial Hepatectomy

NCT06753461 | Completed DMC

• 1 other identifier: 24446-4-01
• Study Type: observational
• Target: 2,600
• Locations: 0 countries
• Sites: N/A

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. 1.Are the intrahepatic blood flow occlusion method, the number of occlusions, and the cumulative occlusion time associated with postoperative cardiac injury?
2. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Myocardial injury after non-cardiac surgery (MINS)

  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

Study Arms (4)

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.

Procedure: intrahepatic blood flow occlusion

Pringle Occlusion

Pringle occlusion was performed throughout the operation.

Procedure: intrahepatic blood flow occlusion

Both Occlusion

Both Pringle occlusion and portal vein block were performed throughout the procedure.

Procedure: intrahepatic blood flow occlusion

Interventions

intrahepatic blood flow occlusion PROCEDURE

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

Both Occlusion; Portal Vein Occlusion; Pringle Occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients aged ≥18 years who underwent partial hepatectomy.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

MeSH Terms

Conditions

Hypotension; Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 31, 2024
• Study Start: November 28, 2014
• Primary Completion: May 20, 2024
• Study Completion: November 20, 2024
• Last Updated: February 20, 2025

Record last verified: 2024-12