UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030144 |
|---|---|
| Receipt number | R000034429 |
| Scientific Title | Association between proton pump inhibitors and benign non-neoplastic gastric lesions. |
| Date of disclosure of the study information | 2017/11/28 |
| Last modified on | 2021/01/26 09:56:38 |
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Basic information
Public title
Association between proton pump inhibitors and benign non-neoplastic gastric lesions.
Acronym
Association between proton pump inhibitors and benign non-neoplastic gastric lesions.
Scientific Title
Association between proton pump inhibitors and benign non-neoplastic gastric lesions.
Scientific Title:Acronym
Association between proton pump inhibitors and benign non-neoplastic gastric lesions.
Region
| Japan |
Condition
Condition
benign non-neoplastic gastric lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate associations between the long-term use of PPIs and the occurrence of multiple white flat lesions (MWFL),or other benign non-neoplastic gastric
lesions such as foveolar hyperplastic polyps or fundic gland polyps. Furthermore to investigate the background of the patients who have MWFL.
Basic objectives2
Others
Basic objectives -Others
Associations between the lesion and the internal use.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations between the long-term use of PPIs and the occurrence of multiple white flat lesions (MWFL).
Key secondary outcomes
Associations between Vonoprazan (VPZ) and the occurrence of MWFL.
Difference in expression of MWFL by type of PPIs and VPZs.
Difference in expression of MWFL due to oral administration period of PPIs and VPZs.
Associations between the long-term use of PPIs or VPZs and the occurrence of benign non-neoplastic gastric lesions such as foveolar hyperplastic polyps or fundic gland polyps.
Features of endoscopic findings (white light, chromoendoscpy, NBI and magnifying NBI imaging) of MWFL.
Features of histopathological findings of MWFL.
Associations between presence of MWFL and Hypergastrinemia.
Associations between presence of MWFL and Helicobacter pylori infection.
Associations between presence of MWFL and atrophic changes of gastric mucosa.
Associations between the long-term use of H2 receptor antagonists and MWFL.
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 who undergo magnifying endoscopy.
Patients who were over 20 years.
Patients who were eligible to this study criteria with written informed consent signed and dated.
Key exclusion criteria
Patients who have risk factor of bleeding after biopsy such as receiving anticoagulation therapy.
Patients who have lesions which cannot be observed because of erosion, ulcer or bleeding.
Patients who have tendency of easy bleeding such as liver cirrhosis, hemophilia or ITP.
Patients who have history of distal or gastorectomy.
Patients who are not eligible to this study due to psychotic disease or psychological symptoms.
Patients whom doctor decide not to register to this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
818-0067
Address
1-1-1 Zokumyoin, Chikushino city, Fukuoka prefecture
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Rino |
| Middle name | |
| Last name | Yamaoka |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
818-0067
Address
1-1-1 Zokumyoin, Chikushino city, Fukuoka prefecture
TEL
092-921-1011
Homepage URL
rinori1222@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital Endoscopy
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka university medical ethics committee
Address
7-45-1 Nanakuma, Jonanku, Fukuoka city, Fukuoka prefecture
Tel
092-801-1011
chikushirinsho@adm.Fukuoka-u.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
福岡大学筑紫病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 28 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although MWFL is suggested to be associated with oral administration of PPIs, there has been no prospective study of relevance.
Management information
Registered date
| 2017 | Year | 11 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034429
