UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050984 |
|---|---|
| Receipt number | R000058115 |
| Scientific Title | Verification of changes in visceral peritoneal tissue associated with continued peritoneal dialysis. |
| Date of disclosure of the study information | 2023/05/03 |
| Last modified on | 2024/04/27 11:34:58 |
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Basic information
Public title
Verification of changes in visceral peritoneal tissue associated with continued peritoneal dialysis.
Acronym
Verification of changes in visceral peritoneal tissue associated with continued peritoneal dialysis.
Scientific Title
Verification of changes in visceral peritoneal tissue associated with continued peritoneal dialysis.
Scientific Title:Acronym
Verification of changes in visceral peritoneal tissue associated with continued peritoneal dialysis.
Region
| Japan |
Condition
Condition
End stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will verify what kind of histological changes in the visceral peritoneum are caused by continuation of peritoneal dialysis.
Basic objectives2
Others
Basic objectives -Others
We will verify what kind of histological changes in the visceral peritoneum are caused by continuation of peritoneal dialysis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Peritoneal submesothelial compact zone thickness measured in each patient
Key secondary outcomes
Measurement of the thickness of the peritoneum itself.
Compare the thickness of the blood vessel wall with the lumen diameter of the vessel and the outer lumen diameter.
Number of blood vessels.
Relationship between the above major and secondary endpoints and clinical data.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients who required laparoscopic peritoneal dialysis-related surgery.
Key exclusion criteria
Patients who do not consent to participate in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Washida |
Organization
School of Medicine and Narita Hospital, International University of Health and Welfare, Narita, Chiba, Japan
Division name
Department of Nephrology
Zip code
286-0124
Address
IUHW Narita Hospital 852 Hatakeda, Narita City, Chiba 286-8520 Japan
TEL
08031522251
ksugita0425@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Sugita |
Organization
International University of Health and Welfare
Division name
Kidney Internal Medicine Course
Zip code
286-0124
Address
IUHW Narita Hospital 852 Hatakeda, Narita City, Chiba 286-8520 Japan
TEL
0476-35-5600
Homepage URL
ksugita0425@yahoo.co.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
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
IUHW Narita Hospital
Address
IUHW Narita Hospital 852 Hatakeda, Narita City, Chiba 286-8520 Japan
Tel
0476-35-5600
ksugita0425@yahoo.co.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
| 2023 | Year | 05 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 05 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058115
