UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022987
Receipt number R000026496
Scientific Title Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy
Date of disclosure of the study information 2016/07/02
Last modified on 2020/07/06 07:34:52

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Basic information

Public title

Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy

Acronym

Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy

Scientific Title

Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy

Scientific Title:Acronym

Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy

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 PTGBA for acute cholecystitis in patients with anti-thrombotic therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy

Key secondary outcomes

Procedure success rate
Safty


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

PTGBA

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 with anti-thrombotic therapy
2) Moderate or severe acute cholecystitis
3) There is no recommend of emergency surgery
4) age =>20

Key exclusion criteria

1) No informed concent
2) Patients with mild cholecystitis
3) Patients with perforation of the gallbladder
4) Patients with pericholecystic abscess
5) Patients with gallbladder cancer
6) Patients with cholangitis
7) Ascitic fluid
8) Pregnancy
9) Cases regarded by doctors as inappropriate for the enrollment for some reasons

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Mitsuhiro
Middle name
Last name Kida

Organization

Kitasato University school of medicine

Division name

Department of Gastroenterology

Zip code

252-0374

Address

1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan

TEL

+81-42-778-8111

Email

m-kida@kitasato-u.ac.jp


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Okuwaki

Organization

Kitasato University School of Medicine

Division name

Department of Gastroenterology

Zip code

2520374

Address

1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan

TEL

+81-42-778-8111

Homepage URL


Email

kokuwaki@kitasato-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology Kitasato University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

N/A

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

Institutional Review Board of Kitasato University

Address

1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan

Tel

+81-42-778-7756

Email

rinri@med.kitasato-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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 02 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

2016 Year 06 Month 28 Day

Date of IRB

2016 Year 06 Month 28 Day

Anticipated trial start date

2016 Year 07 Month 02 Day

Last follow-up date

2020 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 07 Month 02 Day

Last modified on

2020 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name