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

Not Applicable

• Conditions: Liver Neoplasms
• Interventions: Other: Remote ischemia precondition; Other: None remote ischemia precondition

• Registration Number: NCT02168608
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

Remote ischemia precondition could protect the liver from ischemia reperfusion injury in patients undergoing hepatectomy.

Detailed Description

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.

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-18
• Last Update Submitted: 2014-06-18
• Study First Posted: 2014-06-20
• Last Update Posted: 2014-06-20
• Study Start: 2014-09
• Primary Completion: 2015-09
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemia precondition	Remote ischemia precondition	patients in this arm accepted RIPC procedure after induction of anesthesia
None remote ischemia precondition	None remote ischemia precondition	patients in this arm didn't accept RIPC procedure after induction of anesthesia

Primary Outcome Measures

Name	Time	Method
survival rate	30 days postoperatively

Secondary Outcome Measures

Name	Time	Method
alanine aminotransferase (ALT) level in patients' blood	7 days postoperatively	Examine the patients's blood sample for ALT level at 7 days postoperatively
aspartic transaminase (AST) level in patients' blood	7 days postoperatively	Examine the patients's blood sample for AST level at 7 days postoperatively
complications	30 days postoperatively	Number of participants with adverse events within 30 days postoperatively

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, Shanghai, China