UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030144
Receipt No. 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 2017/11/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kensi Yao
Organization Fukuoka University Chikushi Hospital
Division name Endoscopy
Zip code
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
Middle name
Last name Rino Yamaoka
Organization Fukuoka University Chikushi Hospital
Division name Endoscopy
Zip code
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
Address
Tel
Email

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
2017 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034429

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.