Perioperative Myocardial InjuryNCT06753461
Intrahepatic Blood Flow Occlusion and Cardiac Injury Risk in Partial Hepatectomy
An observational study of Perioperative Myocardial Injury and Myocardial Injury After Non-Cardiac Surgery, run by Beijing Tsinghua Chang Gung Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Myocardial Injury, Myocardial Injury After Non-Cardiac Surgery, Hypotension
- What is being tested?
- intrahepatic blood flow occlusion
- Type of treatment
- Surgery or procedure
- How many people
- 2,600 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2014to 20 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients aged ≥18 years who underwent partial hepatectomy.
Who may be able to join
- Hospitalized patients aged ≥18 years who underwent partial hepatectomy between November 28, 2004, and May 20, 2024.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Perioperative Myocardial Injury, Myocardial Injury After Non-Cardiac Surgery, Hypotension, Ischemia Reperfusion Injury
- Being tested
- intrahepatic blood flow occlusion
- Medical subject headings
- Hypotension, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrahepatic blood flow occlusionProcedure or surgery
The specified blood vessel is temporarily clamped to achieve the intended blockage of blood flow.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: intrahepatic blood flow occlusion | |
| Pringle Occlusion | Pringle occlusion was performed throughout the operation. Receives: Procedure: intrahepatic blood flow occlusion | |
| Both Occlusion | Both Pringle occlusion and portal vein block were performed throughout the procedure. Receives: Procedure: intrahepatic blood flow occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 3 days after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start28 Nov 2014
- Primary completion20 May 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhifeng Gao, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753461
- Sponsor's protocol ID
- 24446-4-01
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrahepatic Blood Flow Occlusion Strategies and Postoperative Cardiac Injury Risk in Partial Hepatectomy: a Ten-Year Retrospective Study
- ClinicalTrials.gov ID
- NCT06753461
- Acronym / sponsor ID
- 24446-4-01
- Conditions
- Perioperative Myocardial Injury, Myocardial Injury After Non-Cardiac Surgery, Hypotension, Ischemia Reperfusion Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,600 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 28 Nov 2014 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Occlusion | – | –During the entire operation, no blood flow to the liver was occluded. |
| Portal Vein Occlusion | – | Procedure: intrahepatic blood flow occlusionDuring the entire procedure, only the portal vein was occluded. |
| Pringle Occlusion | – | Procedure: intrahepatic blood flow occlusionPringle occlusion was performed throughout the operation. |
| Both Occlusion | – | Procedure: intrahepatic blood flow occlusionBoth Pringle occlusion and portal vein block were performed throughout the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients aged ≥18 years who underwent partial hepatectomy.
Key inclusion criteria (1 listed)
- Hospitalized patients aged ≥18 years who underwent partial hepatectomy between November 28, 2004, and May 20, 2024.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrahepatic blood flow occlusionThe specified blood vessel is temporarily clamped to achieve the intended blockage of blood flow. | Procedure or surgery | Both Occlusion, Portal Vein Occlusion, Pringle Occlusion |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
Related trials for Perioperative Myocardial Injury
Not yet recruitingObservational study
High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)
Myocardial Infarction (MI), Perioperative Myocardial Injury
Not yet recruiting
Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions
Coronary Heart Disease, Coronary Artery Disease
RecruitingObservational study
Incidence and Outcome of Perioperative Myocardial Injury After Non-cardiac Surgery
Perioperative Myocardial Injury
Enrolling by invitation
Effects of Remimazolam on Postoperative Myocardial Injury
Myocardial Injury
Not yet recruitingObservational study
Nerve Block and Perioperative Myocardial Injury in Elderly Hip Fracture
Hip Fracture, Perioperative Myocardial Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Myocardial Injury and Myocardial Injury After Non-Cardiac Surgery, run by Beijing Tsinghua Chang Gung Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury after non-cardiac surgery (MINS) (time frame: Within 3 days after sugery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.