UMIN-CTR Clinical Trial

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
Email	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
Email	rinori1222@yahoo.co.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034429