UMIN-CTR Clinical Trial

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

benign non-neoplastic gastric lesions

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Fukuoka University Chikushi Hospital

Institute

Department

Personal name

Organization

Fukuoka University Chikushi Hospital Endoscopy

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学筑紫病院（福岡県）

Date of disclosure of the study information

2017

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Although MWFL is suggested to be associated with oral administration of PPIs, there has been no prospective study of relevance.

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