UMIN-CTR Clinical Trial

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
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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
Email	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
Email	chiken@shiga.jcho.go.jp

Sponsor
Institute	Japan Gastroenterological Endoscopy Society
Institute
Department

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
Email	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
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	297
Results	The gland types of IA of criterion-met (normal) and unmet stomachs were significantly different in 6 criteria (p<0.001). The strictest criterion for normal stomach consisted of endoscopic atrophy C0 or C1, histological grade 0 in all the items and serum antibody 3.0U/ml or smaller. Twenty-six subjects were met with the criterion, and the case numbers having fundic, pyloric and transitional glands in IA were 13, 0 and 13, respectively. The 97.5% confidence interval of IA to have pyloric glands was 0-0.132.
Results date posted	2020 Year 03 Month 14 Day
Results Delayed	Delay expected
Results Delay Reason	The study was accepted in Digestive Endoscopy in 2020.
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	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	2020 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021091

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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