![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000018218 |
Receipt No. | 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 | 2020/05/02 |
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 |
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Results Delayed |
|
||||||
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
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 |
|
||||||
Last modified on |
|
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 | |
Registered date | File name |
Research case data | |
Registered date | File name |