Liver NeoplasmsNCT02168608
Remote Ischemia Precondition (RIPC) for Hepatic Protection in Patients Undergoing Hepatectomy
A study testing Remote ischemia precondition and None remote ischemia precondition in people with Liver Neoplasms, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
Remote ischemia precondition could protect the liver from ischemia reperfusion injury in patients undergoing hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Remote ischemia precondition and None remote ischemia precondition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No other main organ diseases, American society of Anesthesiologists (ASA) classification Ⅰ-Ⅱ grade
- Selective hepatectomy, one time hepatic portal occlusion
- Child-Pugh A
Who cannot join
- 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
Show all 10Show fewer
- Refuse to join the research
- Patients with psychopathy
- Acute infection need antibiotic therapy
- Hepatic artery or portal vein embolism
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
Weifeng Yu, professor, 86-10-81875231, ywf808@sohu.com
Weifeng Yu, professor
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Neoplasms
- Being tested
- Remote ischemia precondition, None remote ischemia precondition
- Keywords
- hepatic ischemia reperfusion injury, ischemia precondition, remote ischemia precondition, anti-inflammation
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemia preconditionOther
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 preconditionOther
Placed an uninflated cuff on the right upper arm for 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemia precondition | Experimental | patients in this arm accepted RIPC procedure after induction of anesthesia Receives: Other: Remote ischemia precondition |
| None remote ischemia precondition | Experimental | patients in this arm didn't accept RIPC procedure after induction of anesthesia Receives: Other: None remote ischemia precondition |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: 30 days postoperatively
Secondary outcomes (7)
alanine aminotransferase (ALT) level in patients' blood
Examine the patients's blood sample for ALT level at 1 day postoperatively
Measured: 1 day postoperatively
aspartic transaminase (AST) level in patients' blood
Examine the patients's blood sample for AST level at 1 day postoperatively
Measured: 1 day postoperatively
alanine aminotransferase (ALT) level in patients' blood
Examine the patients's blood sample for ALT level at 3 days postoperatively
Measured: 3 days postoperatively
aspartic transaminase (AST) level in patients' blood
Examine the patients's blood sample for AST level at 3 days postoperatively
Measured: 3 days postoperatively
alanine aminotransferase (ALT) level in patients' blood
Examine the patients's blood sample for ALT level at 7 days postoperatively
Measured: 7 days postoperatively
aspartic transaminase (AST) level in patients' blood
Examine the patients's blood sample for AST level at 7 days postoperatively
Measured: 7 days postoperatively
complications
Number of participants with adverse events within 30 days postoperatively
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-feng Yu, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Weifeng Yu, professor, Study chair, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168608
- Sponsor's protocol ID
- EHBHKY2013-003-006
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15023554Huguet 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.
PubMed 1595841Delva 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.
PubMed 2916865Clavien 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.
PubMed 10903590Azoulay 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.
PubMed 16427543
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemia Precondition for Hepatic Protection in Patients Undergoing Hepatectomy: A Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02168608
- Acronym / sponsor ID
- EHBHKY2013-003-006
- Conditions
- Liver Neoplasms
- Keywords
- hepatic ischemia reperfusion injury, ischemia precondition, remote ischemia precondition, anti-inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemia precondition | Experimental | Other: Remote ischemia preconditionpatients in this arm accepted RIPC procedure after induction of anesthesia |
| None remote ischemia precondition | Experimental | Other: None remote ischemia preconditionpatients in this arm didn't accept RIPC procedure after induction of anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No other main organ diseases, American society of Anesthesiologists (ASA) classification Ⅰ-Ⅱ grade
- Selective hepatectomy, one time hepatic portal occlusion
- Child-Pugh A
Key exclusion criteria (10 listed)
- Peripheral vessels diseases
- Not the same surgical procedure as expected
- Administered anti-inflammatory drugs as glucocorticoid etc
- Diagnosed of diabetes
- History of liver surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemia preconditionThree cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff placed on the right upper arm served as RIPC stimulus. | Other | Remote ischemia precondition |
| None remote ischemia preconditionPlaced an uninflated cuff on the right upper arm for 30 min. | Other | None remote ischemia precondition |
Primary outcome
survival rate
Time frame: 30 days postoperatively
7 secondary outcomes
alanine aminotransferase (ALT) level in patients' blood
Time frame: 1 day postoperatively
aspartic transaminase (AST) level in patients' blood
Time frame: 1 day postoperatively
alanine aminotransferase (ALT) level in patients' blood
Time frame: 3 days postoperatively
aspartic transaminase (AST) level in patients' blood
Time frame: 3 days postoperatively
alanine aminotransferase (ALT) level in patients' blood
Time frame: 7 days postoperatively
aspartic transaminase (AST) level in patients' blood
Time frame: 7 days postoperatively
complications
Time frame: 30 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
- Background: PubMed 15023554Kin 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.
- Background: PubMed 1595841Huguet 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.
- Background: PubMed 2916865Delva 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.
- Background: PubMed 10903590Clavien 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.
- Background: PubMed 16427543Azoulay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weifeng Yu, professor study chair
Eastern Hepatobiliary Surgery Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemia precondition and None remote ischemia precondition in people with Liver Neoplasms, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weifeng Yu, professor (86-10-81875231, ywf808@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02168608, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2014.