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

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

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

Study Overview

• Status: Unknown
• Conditions: Liver Neoplasms
• Intervention / Treatment: Other: Remote ischemia precondition; Other: None remote ischemia precondition

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200438
      • Eastern Hepatobiliary Surgery Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Eastern Hepatobiliary Surgery Hospital
• Investigators: Study Chair: Weifeng Yu, professor, Eastern Hepatobiliary Surgery Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: hepatic ischemia reperfusion injury; ischemia precondition; remote ischemia precondition; anti-inflammation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Ischemia; Liver Neoplasms
• Other Study ID Numbers: EHBHKY2013-003-006