UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015349
Receipt number R000017855
Scientific Title Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis: a prospective feasibility study
Date of disclosure of the study information 2014/10/06
Last modified on 2015/11/10 11:32:24

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Basic information

Public title

Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis: a prospective feasibility study

Acronym

Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis

Scientific Title

Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis: a prospective feasibility study

Scientific Title:Acronym

Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis

Region

Japan


Condition

Condition

Acute cholecystitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Endoscopic transpapillary gallbladder drainage using microguidewire

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Technical success rate, Clinical success rate

Key secondary outcomes

Complications
Increase rate of technical success rate by using microguidewire


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Endoscopic transpapillary gallbladder drainage

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)Patients in whom gallbladder drainage are needed
2)Age >20
3)Written informed consent was obtained.

Key exclusion criteria

1)Cases having difficulty in endoscopic approach
2)Cases with sever complication in other organs
3)Cases without informed consent
4)Cases judged by principal investigator to be inadequate as subjects

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shintaro Hayashi

Organization

Ichinomiya Nishi hospital

Division name

Division of Gastroenterology

Zip code


Address

Kaimei Hira 1, Ichinomiya, Aichi, Japan

TEL

0586-48-0077

Email

sntr.hayashi@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Shintaro Hayashi

Organization

Ichinomiya Nishi hospital

Division name

Division of Gastroenterology

Zip code


Address

Kaimei Hira 1, Ichinomiya, Aichi, Japan

TEL

0586-48-0077

Homepage URL


Email

sntr.hayashi@gmail.com


Sponsor or person

Institute

Ichinomiya Nishi hospital

Institute

Department

Personal name



Funding Source

Organization

Ichinomiya Nishi 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


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

一宮西病院(愛知県)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 06 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

Terminated

Date of protocol fixation

2014 Year 10 Month 06 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 07 Day

Last follow-up date

2015 Year 11 Month 10 Day

Date of closure to data entry

2015 Year 11 Month 10 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 06 Day

Last modified on

2015 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017855


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name