Liver DiseasesKMSNCT00738348
Effect of Perioperative Sivelstat Administration for Liver Resection
A study testing sivelstat and glucose in people with Liver Diseases, run by Kochi University at 1 site in Japan.
Trial summary
It is reported that sivelstat improved and preserved the postoperative renal function in the orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it improved acute lung injury. During liver resection, Pringle maneuver, clamping the hepatoduodenal ligament, was performed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- sivelstat and glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Jul 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- liver disease which surgical management was indicated
Who cannot join
- weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease
Trial locations and contacts
1 site in 1 country.
About this study
It is reported that sivelstat improved and preserved the postoperative renal function in the orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it improved acute lung injury. During liver resection, Pringle maneuver, clamping the hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of the liver by Pringle maneuver.
Read the detailed description
Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.
- Conditions
- Liver Diseases
- Being tested
- sivelstat, glucose
- Keywords
- surgery
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sivelstatDrug
Also called sivelstat sodiumhydrate, ONO PHARMACEUTICAL CO
sivelstat sodiumhydrate
glucoseDrug
glucose
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | 250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour Receives: Drug: sivelstat |
| 1 | Placebo comparator | 250mL of 5% glucose was injected though the vein at 10mL per an hour Receives: Drug: glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of liver damage due to reperfusion injury by Pringle maneuver was measured by several cytokines, including IL-8, IL-6, and HMGB-1.
Measured: during hospitalization
Secondary outcomes (1)
The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takehiro Okabayashi, Kochi University
- Investigators
- Takehiro Okabayashi, MD, PhD, Study director, Kochi Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738348
- Sponsor's protocol ID
- ESAR
- Other IDs
- Kochi University
- Acronym
- KMS
- Status last verified
- Jun 2012
- First submitted
- 18 Aug 2008
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Sivelstat Administration for Liver Resection
- ClinicalTrials.gov ID
- NCT00738348
- Acronym / sponsor ID
- KMS / ESAR
- Conditions
- Liver Diseases
- Keywords
- surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Aug 2008 (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.
It is reported that sivelstat improved and preserved the postoperative renal function in the orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it improved acute lung injury. During liver resection, Pringle maneuver, clamping the hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of the liver by Pringle maneuver.
Detailed description
Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: sivelstat250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour |
| 1 | Placebo comparator | Drug: glucose250mL of 5% glucose was injected though the vein at 10mL per an hour |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- liver disease which surgical management was indicated
Key exclusion criteria (1 listed)
- weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease
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 |
|---|---|---|
| sivelstatAlso: sivelstat sodiumhydrate, ONO PHARMACEUTICAL COsivelstat sodiumhydrate | Drug | 2 |
| glucoseglucose | Drug | 1 |
Primary outcome
The incidence of liver damage due to reperfusion injury by Pringle maneuver was measured by several cytokines, including IL-8, IL-6, and HMGB-1.
Time frame: during hospitalization
1 secondary outcome
The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme
Time frame: during hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
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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.
Takehiro Okabayashi, MD, PhD study director
Kochi Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sivelstat and glucose in people with Liver Diseases, run by Kochi University at 1 site in Japan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jun 2012. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of liver damage due to reperfusion injury by Pringle maneuver was measured by several cytokines, including IL-8, IL-6, and HMGB-1. (time frame: during hospitalization). 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 8 Jun 2012.