UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018352
Receipt number R000021246
Scientific Title Electrocautery vs non-electrocautery dilator catheter of endoscopic ultrasonography (EUS)-guided pancreatic fluid collections drainage
Date of disclosure of the study information 2015/07/21
Last modified on 2015/07/22 14:01:33

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Basic information

Public title

Electrocautery vs non-electrocautery dilator catheter of endoscopic ultrasonography (EUS)-guided pancreatic fluid collections drainage

Acronym

EUS-guided drainage using electrocautery dilation catheter

Scientific Title

Electrocautery vs non-electrocautery dilator catheter of endoscopic ultrasonography (EUS)-guided pancreatic fluid collections drainage

Scientific Title:Acronym

EUS-guided drainage using electrocautery dilation catheter

Region

Japan


Condition

Condition

Pancreatic and peripancreatic fluid collections

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety and utility of electrocautery dilation catheter of EUS-guided pancreatic fluid collections drainage.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

technical and clinical success rates of EUS-guided pancreatic fluid collections drainage using an electrocautery dilation catheter

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

infected and/or symptomatic pancreatic and peripancreatic fluid collections

Key exclusion criteria

coagulopathy, the interposition of vascular on the puncture tract, inability to obtain informed consents

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuya Kitamura

Organization

Showa University School of Medicine

Division name

Division of Gastroenterology, Department of Medicine

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo

TEL

03-3784-8535

Email

k.kitamura@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuya Kitamura

Organization

Showa University School of Medicine

Division name

Division of Gastroenterology, Department of Medicine

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo

TEL

03-3784-8535

Homepage URL


Email

k.kitamura@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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


Address


Tel


Email



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

2015 Year 07 Month 21 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

2015 Year 04 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study
Case control study
Electrocautery group:cases from May 2012 to August 2014
Non-electrocautery group:cases from August 2010 to April 2012


Management information

Registered date

2015 Year 07 Month 20 Day

Last modified on

2015 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name