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

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ClinicalTrials.gov Identifier: NCT02168608
Recruitment Status : Unknown
Verified June 2014 by Wei-feng Yu, Eastern Hepatobiliary Surgery Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2014
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
Wei-feng Yu, Eastern Hepatobiliary Surgery Hospital

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

Condition or disease Intervention/treatment Phase
Liver Neoplasms Other: Remote ischemia precondition Other: None remote ischemia precondition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Remote Ischemia Precondition for Hepatic Protection in Patients Undergoing Hepatectomy: A Single-center Randomized Controlled Trial
Study Start Date : September 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Remote ischemia precondition
patients in this arm accepted RIPC procedure after induction of anesthesia
Other: Remote ischemia precondition
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.

Experimental: None remote ischemia precondition
patients in this arm didn't accept RIPC procedure after induction of anesthesia
Other: None remote ischemia precondition
Placed an uninflated cuff on the right upper arm for 30 min.




Primary Outcome Measures :
  1. survival rate [ Time Frame: 30 days postoperatively ]

Secondary Outcome Measures :
  1. alanine aminotransferase (ALT) level in patients' blood [ Time Frame: 1 day postoperatively ]
    Examine the patients's blood sample for ALT level at 1 day postoperatively

  2. aspartic transaminase (AST) level in patients' blood [ Time Frame: 1 day postoperatively ]
    Examine the patients's blood sample for AST level at 1 day postoperatively

  3. alanine aminotransferase (ALT) level in patients' blood [ Time Frame: 3 days postoperatively ]
    Examine the patients's blood sample for ALT level at 3 days postoperatively

  4. aspartic transaminase (AST) level in patients' blood [ Time Frame: 3 days postoperatively ]
    Examine the patients's blood sample for AST level at 3 days postoperatively

  5. alanine aminotransferase (ALT) level in patients' blood [ Time Frame: 7 days postoperatively ]
    Examine the patients's blood sample for ALT level at 7 days postoperatively

  6. aspartic transaminase (AST) level in patients' blood [ Time Frame: 7 days postoperatively ]
    Examine the patients's blood sample for AST level at 7 days postoperatively

  7. complications [ Time Frame: 30 days postoperatively ]
    Number of participants with adverse events within 30 days postoperatively



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168608


Contacts
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Contact: Weifeng Yu, professor 86-10-81875231 ywf808@sohu.com

Locations
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China, Shanghai
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China, 200438
Contact: Weifeng Yu, professor    86-10-81875231    ywf808@sohu.com   
Principal Investigator: Weifeng Yu, professor         
Sub-Investigator: Zhi Li, MD         
Sub-Investigator: Yuming Sun, MD         
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
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Study Chair: Weifeng Yu, professor Eastern Hepatobiliary Surgery Hospital
Publications:
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Responsible Party: Wei-feng Yu, professor, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT02168608    
Other Study ID Numbers: EHBHKY2013-003-006
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014
Keywords provided by Wei-feng Yu, Eastern Hepatobiliary Surgery Hospital:
hepatic ischemia reperfusion injury
ischemia precondition
remote ischemia precondition
anti-inflammation
Additional relevant MeSH terms:
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Liver Neoplasms
Ischemia
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases