UMIN-CTR Clinical Trial

Public title

Comparing P-CAB to PPI of the effect of Helicobacter pylori testing(urea breath test, stool antigen), and ulcer healing effect after ESD, compared to the post-bleeding

Acronym

P-CAB effects on helicopter flights in antigen -UBT, Japan

Scientific Title

Comparing P-CAB to PPI of the effect of Helicobacter pylori testing(urea breath test, stool antigen), and ulcer healing effect after ESD, compared to the post-bleeding

Scientific Title:Acronym

P-CAB effects on helicopter flights in antigen -UBT, Japan

Region

Japan

Condition

Gastric Adenoma ,Early Gastric Cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Clarify UBT of P-CAB and the influence on antigen during the flight (false-negative rate in particular) in comparison with the PPI, and clarify bleeding protective efficacy more after an ulcer healing promotion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The P-CAB-administered group when compared to the PPI administered group
1.UBT and fecal proof of inspection accuracy of the superiority of antigen
2.evaluation of the superiority of ulcer healing after ESD

Key secondary outcomes

Classify and evaluate in
1.Projectile bleeding
2.Gush-related bleeding
3.Exposure blood vessel
4.Blood clot adhesion
5.Black ulcer
6.Beautiful ulcer
Use a major forceps in Day7 and day28, and find an ulcer area with the approximate value of the area of the oval, and evaluate the reduction ratio, at the time of the endoscope enforcement greater curvature by LCI (Linked color image: Fuji Film Corporation) and perform one place of biopsy and evaluate atrophy, inflammatory cell permeation by Sydney classification

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine	Device,equipment	Maneuver

Interventions/Control_1

PPI treatment (Takepron) after the ESD(A group)

Interventions/Control_2

P-CAB treatment (Takecab) after the ESD(B group)

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

1.patients who have been diagnosed (including suspected)gastric adenoma or early gastric cancer in the treatment before endoscopic diagnosis, (including suspected)
To be an adaptive one of the following case of early gastric cancer.
1) 2cm no differentiated cancer of the following ulcer, gross intra mucosal cancer
2)ulcer without differentiated more than 2cm, gross intramucosal cancer
3)3cm following ulcer of a differentiated, gross intramucosal cancer
4)2cm following ulcer without undifferentiated, gross intra mucosal cancer
2.Patients without Helicobacter pylori history.
3.Gender:unquestioned, Age: patient age at the time of consent acquisition is greater than or equal to 20 years old.
4.Patients Performance Status (PS) is either 0, 1, 2.
5.Patients are able to follow a minimum of 6 months after treatment.
6. Patients who meet the ALT/ALT=<100 IU/L, Cr=<2.0 mg/dl, PT-INR>=80%
7. Patients can receive informed consent from the person

Key exclusion criteria

1.acute abdomen
2.Patients with eradication history of Helicobacter pylori.
3.Patients who are already oral proton pump inhibitor (PPI).
4.Patients of the remaining stomach cancer
5.Patients with gastric tube cancer
6.Patients with endoscopic treatment history with respect to the upper gastrointestinal tract lesions within registered 28 days prior to.
7.Patients with endoscopic therapy plans with respect to the upper gastrointestinal tract lesions within 28 days after treatment.
8.Patients with poorly controlled diabetes (HbA1c> 8.0%)
9.Female patient who during pregnancy or possibility of pregnancy or breastfeeding
10.Patient has been merged with psychosis or psychiatric symptoms, to participate in the test it seems to be difficult
11.Patients complicated with respiratory disease and receiving administration of clarithromycin.
12.Patient corresponding to the contraindication matters of study drug.
13.Other patients principal investigator or researcher has determined to be inappropriate as a target.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyuki Osawa,M.D.,Ph.D

Organization

Jichi Medical University

Division name

Department of Internal Medicine

Zip code

Address

3311-1 Yakushiji,Shimomituke,Tochigi, JAPAN

TEL

0285-58-7539

Email

osawa@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoshimasa Miura,M.D

Organization

Jichi Medical University

Division name

Department of Internal Medicine

Zip code

Address

3311-1 Yakushiji,Shimomituke,Tochigi, JAPAN

TEL

0285-58-7539

Homepage URL

Email

y-miura@jichi.ac.jp

Institute

Jichi Medical University

Institute

Department

Personal name

Organization

FUJIILM Medical Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

15

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

2015

Year

05

Month

26

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

31

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

15

Day

Last modified on

2015

Year

10

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022398