Clinical trial NCT02168608: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Neoplasms
Keywords: hepatic ischemia reperfusion injury
ischemia precondition
remote ischemia precondition
anti-inflammation
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: survival rate
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: alanine aminotransferase (ALT) level in patients' blood
timeFrame: 1 day postoperatively
measure: aspartic transaminase (AST) level in patients' blood
timeFrame: 1 day postoperatively
measure: alanine aminotransferase (ALT) level in patients' blood
timeFrame: 3 days postoperatively
measure: aspartic transaminase (AST) level in patients' blood
timeFrame: 3 days postoperatively
measure: alanine aminotransferase (ALT) level in patients' blood
timeFrame: 7 days postoperatively
measure: aspartic transaminase (AST) level in patients' blood
timeFrame: 7 days postoperatively
measure: complications
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Weifeng Yu, professor
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.