UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018218 |
|---|---|
| Receipt number | R000021091 |
| Scientific Title | Does the mucosa of incisura angularis of stomach belong to fundic or pyloric mucosa? |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2021/05/04 14:37:15 |
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Basic information
Public title
Does the mucosa of incisura angularis of stomach belong to fundic or pyloric mucosa?
Acronym
Mucosa of gastric angulus
Scientific Title
Does the mucosa of incisura angularis of stomach belong to fundic or pyloric mucosa?
Scientific Title:Acronym
Mucosa of gastric angulus
Region
| Japan |
Condition
Condition
Subjects were recruited from the patients who aged 40 years or old, and needed esophagogastroduodenoscopy (EGD) for diagnosis of dyspepsia or health checkup in the participating facilities between March 2008 and February 2009.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether the mucosa of incisura angularis belongs to fundic or pyloric gland region, we conducted a retrospective study which was additively designed to the previous prospective multicenter studies by the expert endoscopists and pathologists in Japan.
Basic objectives2
Others
Basic objectives -Others
We also discussed diagnostic values of the mucosa of incisura angularis of stomach for evaluation of gastric cancer risk in the future.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Normal stomach has a significant tendency to have fundic-type gland mucosa, but not pyloric-type gland mucosa.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects were recruited from the patients who aged 40 years or old, and needed esophagogastroduodenoscopy (EGD) for diagnosis of dyspepsia or health checkup in the participating facilities between March 2008 and February 2009.
Key exclusion criteria
Exclusion criteria were histories of gastric surgery, eradication of H. pylori, treatment with non-steroidal anti-inflammatory drugs, antiplatelet agents, anticoagulants, steroids, antibiotics or proton pump inhibitors within 4 weeks prior to entry, severe liver, renal, or cardiopulmonary dysfunctions or blood diseases including anemia and hemorrhagic tendency.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shigemi |
| Middle name | |
| Last name | Nakajima |
Organization
Japan Community Health care Organization Shiga Hospital
Division name
General Medicine
Zip code
520-0846
Address
16-1 Fujimidai, Otsu, Shiga 520-0846, Japan
TEL
+81-77-537-3101
shigemin@rainbow.plala.or.jp
Public contact
Name of contact person
| 1st name | Shigemi |
| Middle name | |
| Last name | Nakajima |
Organization
Japan Community Health care Organization Shiga Hospital
Division name
General Medicine
Zip code
520-0846
Address
16-1 Fujimidai, Otsu, Shiga 520-0846, Japan
TEL
+81-77-537-3101
Homepage URL
chiken@shiga.jcho.go.jp
Sponsor or person
Institute
Japan Gastroenterological Endoscopy Society
Institute
Department
Personal name
Funding Source
Organization
Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JCHO Shiga Hospital
Address
16-1 Fujimidai, Otsu, Shiga, Japan
Tel
077-537-3101
chiken@shiga.jcho.go.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
地域医療機能推進機構滋賀病院（滋賀県）、新潟大学（新潟県）、国立国際医療センター（東京都）、朝日大学（岐阜県）、その他参加施設
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Dig Endosc. 2021 Jan;33(1):125-132. doi: 10.1111/den.13676. Epub 2020 Jun 23.
Publication of results
Published
Result
URL related to results and publications
Dig Endosc. 2021 Jan;33(1):125-132. doi: 10.1111/den.13676. Epub 2020 Jun 23.
Number of participants that the trial has enrolled
270
Results
A total of 270 subjects were analyzed. The strictest criterion consists of serum antibody=<3.0 U/mL, endoscopic atrophy C-1 and histological grade 0 in all of the five items in Updated Sydney System. The numbers having fundic, transitional and pyloric mucosa at incisura angularis under the strictest criterion were 13 (50%), 13 (50%) and 0, respectively. The probability that the type of mucosa at incisura angularis would be pyloric was almost zero (97.5% confidence interval 0-0.132).
Results date posted
| 2020 | Year | 03 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 23 | Day |
Baseline Characteristics
Written in the paper.
Participant flow
Written in the paper.
Adverse events
non
Outcome measures
Written in the paper.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 31 | Day |
Other
Other related information
Endoscopic atrophy was diagnosed by visibility of the vascular pattern and rugal atrophy, and graded into 8 (C-0 to O-p). Five biopsy specimens were taken and histologically evaluated according to the Updated Sydney system. Gastric glands in incisura angularis (IA) were classified into three types: fundic, pyloric and transitional. Serum antibody to H. pylori was measured. We combined histological grading, endoscopic atrophy and serum antibody to diagnose non-infected normal stomach. We examined 5 criteria for diagnosing normal stomach, and evaluated gastric gland type of IA. In conclusion, the mucosal type of incisura angularis of normal stomach is either fundic or transitional, but not pyloric mucosa.
Management information
Registered date
| 2015 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021091
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