UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037490
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email seijinih@med.hokudai.ac.jp

Sponsor
Institute Kinan Hospital, Deprtment of Nephrology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042734

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.