UMIN-CTR Clinical Trial

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
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	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
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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