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

NCT ID: NCT02168608

Last Updated: 2014-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Remote ischemia precondition

patients in this arm accepted RIPC procedure after induction of anesthesia

Group Type EXPERIMENTAL

Remote ischemia precondition

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

None remote ischemia precondition

Intervention Type OTHER

Placed an uninflated cuff on the right upper arm for 30 min.

Interventions

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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.

Intervention Type OTHER

None remote ischemia precondition

Placed an uninflated cuff on the right upper arm for 30 min.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei-feng Yu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weifeng Yu, professor

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital

Locations

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Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Weifeng Yu, professor

Role: CONTACT

86-10-81875231

Facility Contacts

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Weifeng Yu, professor

Role: primary

86-10-81875231

References

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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.

Reference Type BACKGROUND
PMID: 15023554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1595841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2916865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10903590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16427543 (View on PubMed)

Other Identifiers

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EHBHKY2013-003-006

Identifier Type: -

Identifier Source: org_study_id

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