Remote Ischemia Precondition (RIPC) for Hepatic Protection in Patients Undergoing Hepatectomy

Study Overview
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Brief Summary
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Remote ischemia precondition could protect the liver from ischemia reperfusion injury in patients undergoing hepatectomy.

Detailed Description
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Remote ischemia precondition (RIPC) had been proofed beneficial to ischemia reperfusion injury of heart, kidney, liver, brain and spinal cord in experimentation on animals. And the clinical studies of RIPC were mainly focused on heart, RIPC's protection effect on hepatic ischemia reperfusion injury in patients undergoing hepatectomy still remains unknown, So we designed this study to demonstrate the hypotheses.

Official Title
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Remote Ischemia Precondition for Hepatic Protection in Patients Undergoing Hepatectomy: A Single-center Randomized Controlled Trial

Conditions
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Liver Neoplasms

Intervention / Treatment
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* Other: Remote ischemia precondition
* Other: None remote ischemia precondition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No other main organ diseases, American society of Anesthesiologists (ASA) classification Ⅰ-Ⅱ grade Selective hepatectomy, one time hepatic portal occlusion Child-Pugh A Exclusion Criteria: Peripheral vessels diseases Not the same surgical procedure as expected Administered anti-inflammatory drugs as glucocorticoid etc Diagnosed of diabetes History of liver surgery History of hepatic interventional therapy, radiofrequency therapy,radiotherapy and chemotherapy Refuse to join the research Patients with psychopathy Acute infection need antibiotic therapy Hepatic artery or portal vein embolism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemia precondition<br>patients in this arm accepted RIPC procedure after induction of anesthesia | Other: Remote ischemia precondition<br>* Three cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff placed on the right upper arm served as RIPC stimulus.<br>|
| Experimental: None remote ischemia precondition<br>patients in this arm didn't accept RIPC procedure after induction of anesthesia | Other: None remote ischemia precondition<br>* Placed an uninflated cuff on the right upper arm for 30 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate |  | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alanine aminotransferase (ALT) level in patients' blood | Examine the patients's blood sample for ALT level at 1 day postoperatively | 1 day postoperatively | 
| aspartic transaminase (AST) level in patients' blood | Examine the patients's blood sample for AST level at 1 day postoperatively | 1 day postoperatively | 
| alanine aminotransferase (ALT) level in patients' blood | Examine the patients's blood sample for ALT level at 3 days postoperatively | 3 days postoperatively | 
| aspartic transaminase (AST) level in patients' blood | Examine the patients's blood sample for AST level at 3 days postoperatively | 3 days postoperatively | 
| alanine aminotransferase (ALT) level in patients' blood | Examine the patients's blood sample for ALT level at 7 days postoperatively | 7 days postoperatively | 
| aspartic transaminase (AST) level in patients' blood | Examine the patients's blood sample for AST level at 7 days postoperatively | 7 days postoperatively | 
| complications | Number of participants with adverse events within 30 days postoperatively | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatic ischemia reperfusion injury, ischemia precondition, remote ischemia precondition, anti-inflammation