UMIN-CTR Clinical Trial

Basic information
Public title	study about the association between incision length of EST and recurrence of common bile duct stones
Acronym	study about the association between incision length of EST and recurrence of common bile duct stones
Scientific Title	retrospective study about the association between incision length of EST and recurrence of common bile duct stones
Scientific Title:Acronym	retrospective study about the association between incision length of EST and recurrence of common bile duct stones
Region	Japan

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

Objectives
Narrative objectives1	To clarify the relationship between the size of the EST and DBCS recurrence
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between the size of the EST and CBDS recurrence rate
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients who underwent the elective endoscopic treatment for CBDS in Dokkyo Medical University Hospital between January 2013 and December 2017
Key exclusion criteria	(1)patients with previous papillary dilation or sphincterotomy, (2)patients with reconstruction of intestinal tract, (3)patients with benign or malignant biliary strictures, (4)cases with biliary stenting, (5)cases with incomplete CBDS clearance, (6)cases with endoscopic papillary balloon dilation, and (7)cases without EST
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Irisawa
Organization	Dokkyo Medical University
Division name	gastroenterology
Zip code	3210207
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun,Tochigi-ken
TEL	0282872147
Email	irisawa@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Yoichi Middle name Last name Takimoto
Organization	Dokkyo Medical University
Division name	gastroenterology
Zip code	3210207
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun,Tochigi-ken
TEL	0282872147
Homepage URL
Email	takimoto.yo1@gmail.com

Sponsor
Institute	Dokkyo Medical University
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	Dokkyo Medical University
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun,Tochigi-ken
Tel	0282872147
Email	shonai_hp@dokkyomed.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	R-45-6J
Org. issuing International ID_1	Dokkyo Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 21 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	811
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	2021 Year 04 Month 20 Day
Date of IRB	2021 Year 04 Month 20 Day
Anticipated trial start date	2021 Year 04 Month 20 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a retrospective cohort study conducted in Dokkyo Medical University Hospital. All medical records during January 2013 and December 2020 were reviewed retrospectively.

Management information
Registered date	2021 Year 05 Month 21 Day
Last modified on	2022 Year 05 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050589