Liver TumorsPhase 1/2LTRNCT00845689
Prevention of Liver Damage During Liver Surgery
A Phase 1/2 study testing adenosine and Liver resection in people with Liver Tumors, run by Ludwig-Maximilians - University of Munich.
Trial summary
Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Tumors
- What is being tested?
- adenosine and Liver resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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
- Child, Adult, Older adult
Who may be able to join
- elective resection of liver tumors
- age 18 to 80 years
- informed consent
Who cannot join
- chronic obstructive pulmonary disease
- heart insufficiency NYHA III-IV
- atrio-ventricular conductance blockage II. (Mobitz) or III. degree
- atrial fibrillation
- coronary heart disease (CCS III. or IV. degree)
- arterial hypertension
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- acute renal failure
- increased intracranial pressure
- gout
- pregnancy
About this study
Official title: Study on the Potential Role of Intraoperative Hepatoprotection During Liver Resections
Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. In order to protect the liver from ischemic damage following interventions such as the Pringle Maneuver, preconditioning has been successfully applied in various animal models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet release of endogenuous metabolites, the investigators hypothesize that instead of brief periods of ischemia, the exogenuous infusion of purine analogues may also protect against subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory action of purine ananlogue infusion can further attenuated liver damage.
- Conditions
- Liver Tumors
- Being tested
- placebo, adenosine, Liver resection
- Keywords
- liver surgery
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
NaCl 0,9 %
adenosineDrug
intravenous infusion of adenosine 0, 2 %
adenosineDrug
intravenous infusion of adenosine 0,2 %
Liver resectionProcedure or surgery
Liver resection with Pringle maneuver
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | liver resection with Pringle + placebo Receives: Drug: placebo; Procedure: Liver resection |
| 2 | Active comparator | liver resection with Pringle + adenosine preconditiong Receives: Drug: adenosine; Procedure: Liver resection |
| 3 | Active comparator | liver resection with Pringle + adenosine pre- and postconditioning Receives: Drug: adenosine; Procedure: Liver resection |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorsStudies 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 1/2
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845689
- Sponsor's protocol ID
- LMU-202-LTR
- Acronym
- LTR
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Potential Role of Intraoperative Hepatoprotection During Liver Resections
- ClinicalTrials.gov ID
- NCT00845689
- Acronym / sponsor ID
- LTR / LMU-202-LTR
- Conditions
- Liver Tumors
- Keywords
- liver surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- First posted
- 18 Feb 2009 (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.
Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. In order to protect the liver from ischemic damage following interventions such as the Pringle Maneuver, preconditioning has been successfully applied in various animal models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet release of endogenuous metabolites, the investigators hypothesize that instead of brief periods of ischemia, the exogenuous infusion of purine analogues may also protect against subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory action of purine ananlogue infusion can further attenuated liver damage.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo, Procedure: Liver resectionliver resection with Pringle + placebo |
| 2 | Active comparator | Drug: adenosine, Procedure: Liver resectionliver resection with Pringle + adenosine preconditiong |
| 3 | Active comparator | Drug: adenosine, Procedure: Liver resectionliver resection with Pringle + adenosine pre- and postconditioning |
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- elective resection of liver tumors
- age 18 to 80 years
- informed consent
Key exclusion criteria (10 listed)
- chronic obstructive pulmonary disease
- heart insufficiency NYHA III-IV
- atrio-ventricular conductance blockage II. (Mobitz) or III. degree
- atrial fibrillation
- coronary heart disease (CCS III. or IV. degree)
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 |
|---|---|---|
| placeboNaCl 0,9 % | Drug | 1 |
| adenosineintravenous infusion of adenosine 0, 2 % | Drug | 2 |
| adenosineintravenous infusion of adenosine 0,2 % | Drug | 3 |
| Liver resectionLiver resection with Pringle maneuver | Procedure or surgery | 1, 2, 3 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing adenosine and Liver resection in people with Liver Tumors, run by Ludwig-Maximilians - University of Munich.
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 18 Feb 2009. 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. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 18 Feb 2009; AzTrials last refreshed its copy on 6 Nov 2026.