UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041691
Receipt number R000047591
Scientific Title Prospective examination for making protocol of appropriately using long term indwelling metallic ureteral stent
Date of disclosure of the study information 2020/09/05
Last modified on 2020/09/05 00:20:23

* 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

Prospective examination for making protocol of appropriately using long term indwelling metallic ureteral stent

Acronym

Prospective examination for making protocol of appropriately using long term indwelling metallic ureteral stent

Scientific Title

Prospective examination for making protocol of appropriately using long term indwelling metallic ureteral stent

Scientific Title:Acronym

Prospective examination for making protocol of appropriately using long term indwelling metallic ureteral stent

Region

Japan


Condition

Condition

malignant extrinsic ureteral obstruction

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Hematology and clinical oncology Nephrology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Obstetrics and Gynecology Urology Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect on long term indwelling metallic ureteral stent used for extramural ureteral obstruction due to the progression of malignant tumor and to establish an appropriate management method

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of types of urinary cytokines during use of ureteral stents

Closer examination of biofilms and stones on used ureteral stents

Patency rate

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who performed ureteral stent placement at our hospital and related facilities

Key exclusion criteria

Patients who has bilateral total ureteral obstruction

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Matsui

Organization

Showa University Fujigaoka Hospital

Division name

Urology

Zip code

2270043

Address

1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa

TEL

0459711151

Email

hyperzector555@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Matsui

Organization

Showa University Fujigaoka Hospital

Division name

Urology

Zip code

2270043

Address

1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa

TEL

0459711151

Homepage URL


Email

hyperzector555@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University

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

Showa University Fujigaoka Hospital Clinical Trial Review Committee

Address

1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa

Tel

0459711151

Email

f-irb@cmed.showa-u.ac.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

2020 Year 09 Month 05 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

2020 Year 03 Month 03 Day

Date of IRB

2020 Year 03 Month 10 Day

Anticipated trial start date

2020 Year 03 Month 10 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Regarding to the patients with ureteral obstruction due to malignant tumor, we plan to analyze of urinary cytokines in cases that using a long term indwelling metallic ureteral stent.

In addition, we will evaluate the patient's QOL by correlating with the general condition and biochemical examination, and configurate a protocol for the use of a safe and appropriate long term indwelling metal ureteral stent.


Management information

Registered date

2020 Year 09 Month 05 Day

Last modified on

2020 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047591


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name