UMIN-CTR Clinical Trial

Basic information
Public title	Cross-sectional study on bile acid reflux and Barrett's esophagus, Gastro Esophageal Reflux Disease
Acronym	Bile Acid Reflux and Barrett's Esophagus, GERD
Scientific Title	Cross-sectional study on bile acid reflux and Barrett's esophagus, Gastro Esophageal Reflux Disease
Scientific Title:Acronym	Bile Acid Reflux and Barrett's Esophagus, GERD
Region	Japan

Condition
Condition	Barrett's esophagus, Gastro Esophageal Reflux Disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine the relationship between bile acids refluxed into the stomach and Barrett's esophagus and Gastro Esophageal Reflux Disease.
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between intragastric bile acid concentration and patient background, esophagogastric junction cancer, and gastric reservoir fluid color.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between intragastric bile acid concentration and Barrett's esophagus and Gastro Esophageal Reflux Disease
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 scheduled to undergo upper gastrointestinal endoscopy The participants themselves must have received sufficient explanation of the research and given written consent.
Key exclusion criteria	Patients who require emergency treatment and are difficult to observe normally
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Takatsu
Organization	Yokohama City University Hospital
Division name	Endoscopy Center / Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama-shi Kanaga wa-ken, Japan
TEL	045-787-2800
Email	t196038d@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Takatsu
Organization	Yokohama City University Hospital
Division name	Endoscopy Center / Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama-shi Kanagawa-ken, Japan
TEL	045-787-2800
Homepage URL
Email	t196038d@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
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	Yokohama City University Certified Institutional Review Board
Address	3-9 Fukuura Kanazawa-ku Yokohama-shi Kanagawa-ken, Ja pan, Kanagawa, Kanagawa
Tel	045-370-7627
Email	rinri@yokohama-cu.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	2021 Year 05 Month 24 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	436
Results	Patients with Barrett's esophagus have higher total bile acid concentration (total BA) and certain bile acid fraction concentrations (e.g. Conj CDCA). The Spearman rank correlation coefficient between total BA and Conj CDCA is strongly correlated at 0.95. Total BA, Conj CA, and Conj CDCA are strongly correlated with the color of gastric juice. The color of the intragastric liquid was quantified to obtain a cutoff value (Youden Index) for the presence of Barrett's esophagus (YI 11.3).
Results date posted	2022 Year 05 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The study subjects were patients who underwent gastroscopy at Yokohama City University Hospital from May 7, 2021 to September 31, 2021.
Participant flow	Gastroscopy was performed on patients who had refrained from eating and drinking for a certain period of time, and the esophagus, stomach, and duodenum were observed, intragastric fluid was collected, and biopsies were taken if necessary.
Adverse events	none
Outcome measures	background information (gender, age14,15, height, weight (BMI; Body Mass Index16), life history, preferences, H. pylori infection/elimination, previous history, surgical history, complications, and regular medications), last time they drank water, purpose of gastroscopy, Color of intragastric liquid and bile acid concentrations in stomach
Plan to share IPD	none
IPD sharing Plan description	none

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 03 Month 19 Day
Date of IRB	2021 Year 04 Month 30 Day
Anticipated trial start date	2021 Year 05 Month 07 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2022 Year 01 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other

Other related information

Gastric fluid and clinical information obtained in the course of normal medical care should be collected. Gastric fluid and endoscopic findings will be collected at the time of upper gastrointestinal endoscopy (including pathology results). Based on the information obtained, the relationship between intragastric bile acid concentration and Barrett's esophagus and Gastro Esophageal Reflux Disease will be investigated.

Management information
Registered date	2021 Year 05 Month 24 Day
Last modified on	2022 Year 05 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050595