UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042079
Receipt number R000043307
Scientific Title A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis
Date of disclosure of the study information 2020/10/12
Last modified on 2020/10/11 17:12:51

* 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

A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis

Acronym

A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis

Scientific Title

A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis

Scientific Title:Acronym

A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube 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

The purpose of this study was to evaluate the long-term prognosis of gallbladder stent placement using nasobiliary drainage tube (BLADE) performed in patients who had not undergone cholecystectomy for acute cholecystitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Recurrence rate of cholecystitis

Key secondary outcomes

The incidence of late adverse events, procedure success 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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent the BLADE procedure from April 2014 to December 2018 and did not perform cholecystectomy.

Key exclusion criteria

Patients who underwent BLADE procedure during the same period and performed cholecystectomy within 3 months.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shinpei
Middle name
Last name Doi

Organization

Teikyo University School of medicine University Mizonokuchi Hospital

Division name

Dept of Gastroenterology

Zip code

213-8507

Address

5-1-1, Futago, Takatsu-ku, Kawasaki city, Kanagawa pref

TEL

044-844-3333

Email

sinpesan@gmail.com


Public contact

Name of contact person

1st name Shinpei
Middle name
Last name Doi

Organization

Teikyo University School of medicine University Mizonokuchi Hospital

Division name

Dept of Gastroenterology

Zip code

213-8507

Address

5-1-1, Futago, Takatsu-ku, Kawasaki city, Kanagawa pref

TEL

044-844-3333

Homepage URL


Email

sinpesan@gmail.com


Sponsor or person

Institute

Teikyo University School of medicine University Mizonokuchi Hospital

Institute

Department

Personal name



Funding Source

Organization

Teikyo University School of medicine University Mizonokuchi Hospital

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

Teikyo University Ethics Committee Secretariat

Address

2-11-1, Kaga, Itabashi-ku, Tokyo

Tel

03-3964-7256

Email

turb-office@teikyo-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

帝京大学医学部附属溝口病院


Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 12 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

50

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

2019 Year 02 Month 25 Day

Date of IRB

2019 Year 12 Month 31 Day

Anticipated trial start date

2019 Year 12 Month 31 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Data has been aggregated and analysis is in progress.


Management information

Registered date

2020 Year 10 Month 11 Day

Last modified on

2020 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043307


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name