UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040510
Receipt number R000046124
Scientific Title Safety and effectiveness of EUS-GBD using a metal stent with a metal stent with larger diameter head: a prospective study
Date of disclosure of the study information 2020/05/25
Last modified on 2021/11/25 10:45:46

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Basic information

Public title

A prospective study to assess the efficacy and safety of endoscopic ultrasound-guided gallbladder drainage using a metal stent with larger diameter head

Acronym

A prospective study to assess the efficacy and safety of EUS-GBD using a metal stent with larger diameter head

Scientific Title

Safety and effectiveness of EUS-GBD using a metal stent with a metal stent with larger diameter head: a prospective study

Scientific Title:Acronym

Safety and effectiveness of EUS-GBD using a metal stent with a metal stent with larger diameter head: a prospective study

Region

Japan


Condition

Condition

Acute cholecystitis

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to evaluate the efficacy and safety of EUS-GBD using a metal stent with larger diameter head

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy (Technical success rate, Functional success rate, migration rate)

Key secondary outcomes

Safety (Adverse events rate)


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patient with acute cholecystitis who is planned for EUS-GBD
2) Age >20
3) Written informed consent

Key exclusion criteria

1) PS 4
2) Patients who cannot stop antithrombotic drugs
3) Pregnant woman
4) Platelet < 50000/uL
5) PT-INR > 1.5
6) Inappropriate patient

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hirotoshi
Middle name
Last name Ishiwatari

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

411-8777

Address

1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka

TEL

055-989-5222

Email

ishihiro481019@gmail.com


Public contact

Name of contact person

1st name Hirotoshi
Middle name
Last name Ishiwatari

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

411-8777

Address

1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka

TEL

055-989-5222

Homepage URL


Email

ishihiro481019@gmail.com


Sponsor or person

Institute

Division of Endoscopy, Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

No funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shizuoka Cancer Center

Address

1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka

Tel

055-989-5222

Email

ishihiro481019@gmail.com


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

静岡がんセンター


Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 25 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

5

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

Terminated

Date of protocol fixation

2020 Year 04 Month 20 Day

Date of IRB

2020 Year 05 Month 15 Day

Anticipated trial start date

2020 Year 05 Month 25 Day

Last follow-up date

2023 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In the prospective study, we will evaluate the technical/ functional success rate and stent migration rate. Stent migration is defined as completely or partially migrated stent into the gall bladder or the gastrointestinal tract. We will evaluate adverse events including stent migration through scheduled follow-up until patient death or 1 year after stent placement.


Management information

Registered date

2020 Year 05 Month 25 Day

Last modified on

2021 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name