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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019372
Enrollment
100
Registered
2015-10-15
Start date
2015-10-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Adenoma ,Early Gastric Cancer

Interventions

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

Sponsors

Jichi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYoshimasa Miura,M.D

Jichi Medical University Department of Internal Medicine

y-miura@jichi.ac.jp0285-58-7539

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026