Kidney CancerPhase 4NCT04162834
Effect of Papaverine on Renal Artery Blood Flow Volume
A Phase 4 study testing Papaverine and Normal saline in people with Kidney Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Papaverine and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Nov 2019to 15 Apr 2021
- Phase
- Phase 4
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with kidney cancer.
- Patients undergoing robot assisted partial nephrectomy under general anesthesia
- 20 years old ≤ age <80 years old
- Patients who voluntarily agreed to this clinical study
- eGFR ≥ 60 ml / min / 1.73 m2 (Chronic Kidney Disease Epidemiology Patients with Collaboration)
Who cannot join
- The tumor ≥ 7 cm in size
- Multiple renal mass
- If the surgery plan is changed due to open
- When surgery is performed together with other surgery
- Multiple renal artery
- Patients with hypersensitivity to papaverine
Show all 10Show fewer
- Patients with atrioventricular block
- Pregnant and lactating women
- Patients using levodopa
- Refusal of patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Placebo-controlled Study
The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery.
Read the detailed description
The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery in patients undergoing robot assisted partial nephrectomy.
- Conditions
- Kidney Cancer
- Being tested
- Papaverine, Normal saline
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PapaverineDrug
Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.
Normal salineDrug
Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.
| Study group | Role | What they receive |
|---|---|---|
| Papaverine group | Experimental | Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery. Receives: Drug: Papaverine |
| Normal saline group | Active comparator | Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal artery blood flow
Renal artery blood flow 2 minutes after papaverine administration by doppler sonography
Measured: at 2 minutes after papaverine administration
Secondary outcomes (6)
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
Measured: at postoperative day 0
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
Measured: at postoperative day 1
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
Measured: at postoperative day 4
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
Measured: at postoperative day 14
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
Measured: at postoperative month 3
glomerular filtration rate using renal scan
glomerular filtration rate using renal scan
Measured: at postoperative month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start21 Nov 2019
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, MD, Asan Medical Center
- Investigators
- Young-Kug Kim, MD,PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162834
- Sponsor's protocol ID
- 20191111
- Status last verified
- Apr 2021
- First submitted
- 10 Nov 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04162834
- Acronym / sponsor ID
- 20191111
- Conditions
- Kidney Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 14 Nov 2019 (actual)
- 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 purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery.
Detailed description
The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery in patients undergoing robot assisted partial nephrectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papaverine group | Experimental | Drug: PapaverineImmediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery. |
| Normal saline group | Active comparator | Drug: Normal salineImmediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with kidney cancer.
- Patients undergoing robot assisted partial nephrectomy under general anesthesia
- 20 years old ≤ age <80 years old
- Patients who voluntarily agreed to this clinical study
- eGFR ≥ 60 ml / min / 1.73 m2 (Chronic Kidney Disease Epidemiology Patients with Collaboration)
Key exclusion criteria (10 listed)
- The tumor ≥ 7 cm in size
- Multiple renal mass
- If the surgery plan is changed due to open
- When surgery is performed together with other surgery
- Multiple renal artery
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 |
|---|---|---|
| PapaverineImmediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery. | Drug | Papaverine group |
| Normal salineImmediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery. | Drug | Normal saline group |
Primary outcome
Renal artery blood flow
Time frame: at 2 minutes after papaverine administration
Renal artery blood flow 2 minutes after papaverine administration by doppler sonography
6 secondary outcomes
estimated glomerular filtration rate
Time frame: at postoperative day 0
estimated glomerular filtration rate
Time frame: at postoperative day 1
estimated glomerular filtration rate
Time frame: at postoperative day 4
estimated glomerular filtration rate
Time frame: at postoperative day 14
estimated glomerular filtration rate
Time frame: at postoperative month 3
glomerular filtration rate using renal scan
Time frame: at postoperative month 3
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 19 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Young-Kug Kim, MD,PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Papaverine and Normal saline in people with Kidney Cancer, run by Asan Medical Center at 1 site in South Korea.
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 5 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: finished, as of the sponsor's last update on 19 Apr 2021. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Renal artery blood flow (time frame: at 2 minutes after papaverine administration). 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 19 Apr 2021.