UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037490 |
|---|---|
| Receipt number | R000042734 |
| Scientific Title | Examination of the quality and complications of diagnosis in percutaneous kidney biopsy affected by difference of biopsy needle |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2019/07/25 15:56:43 |
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Basic information
Public title
Examination of the quality and complications of diagnosis in percutaneous kidney biopsy affected by difference of biopsy needle
Acronym
Are there differences in quality and complications due to differences in biopsy needles?
Scientific Title
Examination of the quality and complications of diagnosis in percutaneous kidney biopsy affected by difference of biopsy needle
Scientific Title:Acronym
Are there differences in quality and complications due to differences in biopsy needles?
Region
| Japan |
Condition
Condition
CKD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with kidney disease, kidney biopsy is an important test for identifying the cause of kidney disease, predicting prognosis, and determining treatment. Percutaneous kidney biopsy has been started since 1951 and safe and efficient kidney biopsy has become possible by introducing an echo guide and an automatic biopsy needle, but it is still an examination with a risk of complications . It is important in renal biopsy practice to minimize complications such as pain and hemorrhage while securing kidney tissue fragments useful for diagnosis. A piece of kidney tissue useful for diagnosis is one of the conditions having more glomeruli in the piece of tissue, which is considered to be correlated to the size of the piece of kidney tissue. However, obtaining larger pieces of kidney tissue may increase the risk of damage to arteries and surrounding tissues, and may increase complications. In overseas RCT reports, there are two reports on the examination quality and complications of renal biopsy influenced by the size of the needle for biopsy of the kidney. It is reported that the larger the size of the kidney biopsy needle, the better the quality of diagnosis, but the pain is increased as a complication. There is no choice but to consider it an inadequate review. Japanese people are smaller in physical size and smaller in kidney size than in foreign countries, so it may be difficult to adapt as is the case with foreign RCT background factors. In this study, we will compare the quality and complication of diagnosis of kidney biopsy using 16G and 18G kidney biopsy needles, and aim to help selection of more effective biopsy needles.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Is there a difference in safety regardless of the difference in the biopsy needle? In particular, is the amount of bleeding different between two groups? Is there a difference in the number of collected glomeruli?
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We randomly assign renal biopsy patients to be performed at our hospital to those using a 16G puncture needle and those using an 18G puncture needle. All other methods are performed with the same protocol in both groups, with the only difference being the gauge of the needle. Record changes in bleeding volume, Hb, renal function, etc. in both groups. Count the number of glomeruli of collected samples and examine whether there is a difference between the two groups
Interventions/Control_2
We randomly assign renal biopsy patients to be performed at our hospital to those using a 16G puncture needle and those using an 18G puncture needle. All other methods are performed with the same protocol in both groups, with the only difference being the gauge of the needle. Record changes in bleeding volume, Hb, renal function, etc. in both groups. Count the number of glomeruli of collected samples and examine whether there is a difference between the two groups
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic kidney disease who undergo a kidney biopsy at our hospital are included in this study. Patients should be informed after sufficient explanation.
Key exclusion criteria
Patients who do not give consent.
Those who have a tendency to bleed. Specifically, those who are abnormal in the platelet count and PT and APTT tests are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hashimoto |
Organization
Kinan Hospital
Division name
Department of Nephrology
Zip code
646-8588
Address
46-70 Shinjyou-machi, Tanabe
TEL
0739-22-5000
seijinih@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | seiji |
| Middle name | |
| Last name | Hashimoto |
Organization
Kinan Hospital
Division name
Department Of Nephrology
Zip code
646-8588
Address
46-70 Shinjyou-machi, Tanabe
TEL
0739-22-5000
Homepage URL
seijinih@med.hokudai.ac.jp
Sponsor or person
Institute
Kinan Hospital, Deprtment of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Kinan Hospital, Deprtment of Nephrology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kinan
Address
46-70 Shinjyou-machi, Tanabe
Tel
0739-22-5000
shomu@kinan-hp.tanabe.wakayama.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 25 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042734
