UMIN-CTR Clinical Trial

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