UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term outcomes in patients with gallstones detected by mass screening
Title of the study (Brief title)	Long-term outcomes of gallstones
Region	Japan

Condition
Condition	gallstones
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate outcomes in patients with gallstones detected by mass survey
Basic objectives2	Others
Basic objectives -Others	To evaluate clinical features of those requiring surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare individuals requiring or not requiring cholecystectomy as to clinical features
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	patients with gallstones detected by mass survey
Key exclusion criteria	Persons who do not agree with participation in the study
Target sample size	720

Research contact person
Name of lead principal investigator	Kazuo Inui
Organization	Second Teaching Hospital, Fujita Health University
Division name	Department of Gastroenterology
Address	3-6-10, Otobashi, Nakagawa-ku, Nagoya 454-8509, Japan
TEL	052-321-8171
Email	kinui@fujita-hu.ac.jp

Public contact
Name of contact person	Kazuo Inui
Organization	Second Teaching Hospital, Fujita Health University
Division name	Department of Gastroenterology
Address	3-6-10, Otobashi, Nakagawa-ku, Nagoya 454-8509, Japan
TEL	052-321-8171
Homepage URL	http://www.fujita-hu.ac.jp/HOSPITAL2/
Email	kinui@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 19 Day
Anticipated trial start date	2016 Year 04 Month 25 Day
Last follow-up date	2016 Year 08 Month 20 Day
Date of closure to data entry	2016 Year 08 Month 20 Day
Date trial data considered complete	2016 Year 09 Month 28 Day
Date analysis concluded	2016 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Among persons with gallstones detected by screening, men who drank, had abdominal symptoms, and showed gallbladder wall thickening or adenomyomatosis were more likely to require surgery within 4 years.
Other related information	presented at American Gastroenterology Association in 2015. published on the expert journal, JHBPS in Oct. 2016.

Management information
Registered date	2016 Year 04 Month 20 Day
Last modified on	2017 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025340