search
Back to results

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

Primary Purpose

Liver Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemia precondition
None remote ischemia precondition
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Neoplasms focused on measuring hepatic ischemia reperfusion injury, ischemia precondition, remote ischemia precondition, anti-inflammation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern Hepatobiliary Surgery Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Remote ischemia precondition

None remote ischemia precondition

Arm Description

patients in this arm accepted RIPC procedure after induction of anesthesia

patients in this arm didn't accept RIPC procedure after induction of anesthesia

Outcomes

Primary Outcome Measures

survival rate

Secondary Outcome Measures

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

Full Information

First Posted
June 11, 2014
Last Updated
June 18, 2014
Sponsor
Eastern Hepatobiliary Surgery Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02168608
Brief Title
Remote Ischemia Precondition (RIPC) for Hepatic Protection in Patients Undergoing Hepatectomy
Official Title
Remote Ischemia Precondition for Hepatic Protection in Patients Undergoing Hepatectomy: A Single-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms
Keywords
hepatic ischemia reperfusion injury, ischemia precondition, remote ischemia precondition, anti-inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemia precondition
Arm Type
Experimental
Arm Description
patients in this arm accepted RIPC procedure after induction of anesthesia
Arm Title
None remote ischemia precondition
Arm Type
Experimental
Arm Description
patients in this arm didn't accept RIPC procedure after induction of anesthesia
Intervention Type
Other
Intervention Name(s)
Remote ischemia precondition
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
None remote ischemia precondition
Intervention Description
Placed an uninflated cuff on the right upper arm for 30 min.
Primary Outcome Measure Information:
Title
survival rate
Time Frame
30 days postoperatively
Secondary Outcome Measure Information:
Title
alanine aminotransferase (ALT) level in patients' blood
Description
Examine the patients's blood sample for ALT level at 1 day postoperatively
Time Frame
1 day postoperatively
Title
aspartic transaminase (AST) level in patients' blood
Description
Examine the patients's blood sample for AST level at 1 day postoperatively
Time Frame
1 day postoperatively
Title
alanine aminotransferase (ALT) level in patients' blood
Description
Examine the patients's blood sample for ALT level at 3 days postoperatively
Time Frame
3 days postoperatively
Title
aspartic transaminase (AST) level in patients' blood
Description
Examine the patients's blood sample for AST level at 3 days postoperatively
Time Frame
3 days postoperatively
Title
alanine aminotransferase (ALT) level in patients' blood
Description
Examine the patients's blood sample for ALT level at 7 days postoperatively
Time Frame
7 days postoperatively
Title
aspartic transaminase (AST) level in patients' blood
Description
Examine the patients's blood sample for AST level at 7 days postoperatively
Time Frame
7 days postoperatively
Title
complications
Description
Number of participants with adverse events within 30 days postoperatively
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Yu, professor
Phone
86-10-81875231
Email
ywf808@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weifeng Yu, professor
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weifeng Yu, professor
Phone
86-10-81875231
Email
ywf808@sohu.com
First Name & Middle Initial & Last Name & Degree
Weifeng Yu, professor
First Name & Middle Initial & Last Name & Degree
Zhi Li, MD
First Name & Middle Initial & Last Name & Degree
Yuming Sun, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15023554
Citation
Kin H, Zhao ZQ, Sun HY, Wang NP, Corvera JS, Halkos ME, Kerendi F, Guyton RA, Vinten-Johansen J. Postconditioning attenuates myocardial ischemia-reperfusion injury by inhibiting events in the early minutes of reperfusion. Cardiovasc Res. 2004 Apr 1;62(1):74-85. doi: 10.1016/j.cardiores.2004.01.006.
Results Reference
background
PubMed Identifier
1595841
Citation
Huguet C, Addario-Chieco P, Gavelli A, Arrigo E, Harb J, Clement RR. Technique of hepatic vascular exclusion for extensive liver resection. Am J Surg. 1992 Jun;163(6):602-5. doi: 10.1016/0002-9610(92)90567-b.
Results Reference
background
PubMed Identifier
2916865
Citation
Delva E, Camus Y, Nordlinger B, Hannoun L, Parc R, Deriaz H, Lienhart A, Huguet C. Vascular occlusions for liver resections. Operative management and tolerance to hepatic ischemia: 142 cases. Ann Surg. 1989 Feb;209(2):211-8. doi: 10.1097/00000658-198902000-00012.
Results Reference
background
PubMed Identifier
10903590
Citation
Clavien PA, Yadav S, Sindram D, Bentley RC. Protective effects of ischemic preconditioning for liver resection performed under inflow occlusion in humans. Ann Surg. 2000 Aug;232(2):155-62. doi: 10.1097/00000658-200008000-00001.
Results Reference
background
PubMed Identifier
16427543
Citation
Azoulay D, Lucidi V, Andreani P, Maggi U, Sebagh M, Ichai P, Lemoine A, Adam R, Castaing D. Ischemic preconditioning for major liver resection under vascular exclusion of the liver preserving the caval flow: a randomized prospective study. J Am Coll Surg. 2006 Feb;202(2):203-11. doi: 10.1016/j.jamcollsurg.2005.10.021.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs