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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02168608
• Other study ID #: EHBHKY2013-003-006
• Status: Not yet recruiting
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 18, 2014
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2014
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Weifeng Yu, professor
• Phone: 86-10-81875231
• Email: ywf808[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• No other main organ diseases, American society of Anesthesiologists (ASA) classification ?-? 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ischemia
• Liver Neoplasms

Intervention

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.
• None remote ischemia precondition
Placed an uninflated cuff on the right upper arm for 30 min.

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate		30 days postoperatively	Yes
Secondary	alanine aminotransferase (ALT) level in patients' blood	Examine the patients's blood sample for ALT level at 1 day postoperatively	1 day postoperatively	Yes
Secondary	aspartic transaminase (AST) level in patients' blood	Examine the patients's blood sample for AST level at 1 day postoperatively	1 day postoperatively	Yes
Secondary	alanine aminotransferase (ALT) level in patients' blood	Examine the patients's blood sample for ALT level at 3 days postoperatively	3 days postoperatively	Yes
Secondary	aspartic transaminase (AST) level in patients' blood	Examine the patients's blood sample for AST level at 3 days postoperatively	3 days postoperatively	Yes
Secondary	alanine aminotransferase (ALT) level in patients' blood	Examine the patients's blood sample for ALT level at 7 days postoperatively	7 days postoperatively	Yes
Secondary	aspartic transaminase (AST) level in patients' blood	Examine the patients's blood sample for AST level at 7 days postoperatively	7 days postoperatively	Yes
Secondary	complications	Number of participants with adverse events within 30 days postoperatively	30 days postoperatively	Yes