Some Studies Shows That the Steroid Can Reduce the Injury of the I/R of the LiverNCT01608945
Prospective Randomized Study of Glucocorticoids in the Impact of the Liver Function and the Prognosis After Hepatectomy of HCC
An observational study of Some Studies Shows That the Steroid Can Reduce the Injury of the I/R of the Liver, run by Eastern Hepatobiliary Surgery Hospital.
Trial summary
The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with impairment of liver function. Perioperative steroid administration has been advocated to reduce liver damage. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Some Studies Shows That the Steroid Can Reduce the Injury of the I/R of the Liver
- What is being tested?
- Hydrocortisone sodium succinate
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to not given
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60
Who may be able to join
- 18-70 years old
- diametre of the mass>3cm.
- hcc
Who cannot join
None listed.
About this study
The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with impairment of liver function. Perioperative steroid administration has been advocated to reduce liver damage. The aim of this prospective, randomized study was to determine whether steroid administration can reduce liver injury and impact the prognosis
- Being tested
- Hydrocortisone sodium succinate
- Keywords
- steroid, liver function, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone sodium succinateDrug
100mg/day
| Study group | Role | What they receive |
|---|---|---|
| steroid,liver function I/R | Not described Receives: Drug: Hydrocortisone sodium succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver function
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Some Studies Shows That the Steroid Can Reduce the Injury of the I/R of the LiverStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jian zhai, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608945
- Sponsor's protocol ID
- EHBH112
- Status last verified
- May 2012
- First submitted
- 29 May 2012
- Last updated
- 31 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Glucocorticoids in the Impact of the Liver Function and the Prognosis After Hepatectomy of HCC
- ClinicalTrials.gov ID
- NCT01608945
- Acronym / sponsor ID
- EHBH112
- Keywords
- steroid, liver function, prognosis
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Apr 2008
- First posted
- 31 May 2012 (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.
The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with impairment of liver function. Perioperative steroid administration has been advocated to reduce liver damage. The aim of this prospective, randomized study was to determine whether steroid administration can reduce liver injury and impact the prognosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| steroid,liver function I/R | – | Drug: Hydrocortisone sodium succinate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60
Key inclusion criteria (3 listed)
- 18-70 years old
- diametre of the mass>3cm.
- hcc
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hydrocortisone sodium succinate100mg/day | Drug | steroid,liver function I/R |
Primary outcome
liver function
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Some Studies Shows That the Steroid Can Reduce the Injury of the I/R of the Liver, run by Eastern Hepatobiliary Surgery Hospital.
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 0 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: paused, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver function (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2012.