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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022987
Receipt No. 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 2016/07/02

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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
Middle name
Last name Mitsuhiro Kida
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code
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
Middle name
Last name Kosuke Okuwaki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
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
Institute Department of Gastroenterology Kitasato University School of Medicine
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 02 Day
Last follow-up date
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
2016 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.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


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