UMIN-CTR Clinical Trial

Basic information
Public title	Endoscopic papillary balloon dilation can be safely performed in patients with dual antiplatelet therapy: A pilot study
Acronym	Endoscopic papillary balloon dilation is safe for patients with dual antiplatelet therapy
Scientific Title	Endoscopic papillary balloon dilation can be safely performed in patients with dual antiplatelet therapy: A pilot study
Scientific Title:Acronym	Endoscopic papillary balloon dilation is safe for patients with dual antiplatelet therapy
Region	Japan

Condition
Condition	common bile duct stone
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	investigation for safe
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	bleeding
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	with antiplatelet thrapy
Key exclusion criteria	without antiplatelet thrapy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Sakue Middle name Last name Masuda
Organization	Shonan Kamakura General Hospital
Division name	Gastrointestinal Medicine Center
Zip code	247-8533
Address	1370-1 Okamoto, Kamakura, Kanagawa
TEL	0467-46-1717
Email	sakue3939@yahoo.co.jp

Public contact
Name of contact person	1st name Sakue Middle name Last name Masuda
Organization	Shonan Kamakura General Hospital
Division name	Gastrointestinal Medicine Center
Zip code	247-8533
Address	1370-1 Okamoto, Kamakura, Kanagawa
TEL	0467-46-1717
Homepage URL
Email	sakue3939@yahoo.co.jp

Sponsor
Institute	Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization	none
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	mirai-iryo
Address	1-7-8 Kojimachi, Chiyoda, Tokyo
Tel	03-3263-4801
Email	tajima@mirai-iryo.com

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	2022 Year 10 Month 18 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	31
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	2014 Year 04 Month 01 Day
Date of IRB	2022 Year 10 Month 18 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2022 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	EPBD for DAPT or SAPT groups.

Management information
Registered date	2022 Year 10 Month 13 Day
Last modified on	2022 Year 10 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056049