UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044301 |
|---|---|
| Receipt number | R000050595 |
| Scientific Title | Cross-sectional study on bile acid reflux and Barrett's esophagus, Gastro Esophageal Reflux Disease |
| Date of disclosure of the study information | 2021/05/24 |
| Last modified on | 2022/05/25 17:42:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
t196038d@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050595
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
