UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035569
Receipt number R000040524
Scientific Title The study of the effectiveness and troubleshooting for endoscopic necrosectomy with lumen-apposing metal stent
Date of disclosure of the study information 2019/01/16
Last modified on 2024/02/25 12:15:19

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Basic information

Public title

The study of the effectiveness and troubleshooting for endoscopic necrosectomy with lumen-apposing metal stent

Acronym

The effectiveness and troubleshooting for endoscopic necrosectomy with lumen-apposing metal stent

Scientific Title

The study of the effectiveness and troubleshooting for endoscopic necrosectomy with lumen-apposing metal stent

Scientific Title:Acronym

The effectiveness and troubleshooting for endoscopic necrosectomy with lumen-apposing metal stent

Region

Japan


Condition

Condition

pancreatic pseudocyst or walled-off necrosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness for endoscopic necrosectomy with lumen-apposing metal stent including troubleshooting

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The effectiveness for endoscopic necrosectomy with lumen-apposing metal stent

Key secondary outcomes

The adverse events of endoscopic necrosectomy with lumen-apposing metal stent


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

The patients who had infected walled-off necrosis or pancreatic pseudocyst and treated endoscopic necrosectomy with lumen-apposing metal stent

Key exclusion criteria

he patients who are otherwise judged by the investigator to be ineligible to participate in the study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name mitsuru
Middle name
Last name okuno

Organization

Gifu Municipal Hospital

Division name

Department of Gastroenterology

Zip code

5008513

Address

7-1 Kasima-cho, Gifu city, Gifu

TEL

058-251-1101

Email

mkobdkl@yahoo.co.jp


Public contact

Name of contact person

1st name mitsuru
Middle name
Last name Okuno

Organization

Gifu Municipal Hospital

Division name

Department of Gastroenterology

Zip code

5008513

Address

7-1 Kashima-cho, Gifu city, Gifu

TEL

058-251-1101

Homepage URL


Email

mkobdkl@yahoo.co.jp


Sponsor or person

Institute

Gifu Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Gifu Municipal Hospital

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

gifu municipal hospital

Address

kashimacho 7-1, gifu city,gifu pref.

Tel

058-251-1101

Email

mkobdkl@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

2019 Year 01 Month 16 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

Completed

Date of protocol fixation

2018 Year 10 Month 01 Day

Date of IRB

2018 Year 10 Month 01 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2043 Year 12 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

2019 Year 01 Month 16 Day

Last modified on

2024 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name