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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03924375
Other study ID # SCH-HP-2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2019
Est. completion date May 31, 2020

Study information

Verified date July 2020
Source Soonchunhyang University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Helicobacter pylori has been recognized as a major pathogen in gastric carcinogenesis. Current guidelines recommend the H. pylori "test-and-treat" strategy for the purpose of primary and secondary gastric cancer prevention. Considering the "point of no return" theory, however, H. pylori eradication cannot reduce the risk of gastric cancer in subjects with gastric atrophy and intestinal metaplasia. The intragastric hypoacidic environment is associated with the risk of intestinal-type gastric cancer development. Recently, the secretory ability of the stomach can be measured using the serum pepsinogen (PG) assay.


Description:

This study aimed to evaluate the change of serum PGs after H. pylori eradication success and identify the optimal timing of eradication.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 31, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Gastroscopy can be performed

- Serologic markers including serum pepsinogen can be measured

Exclusion Criteria:

- Age < 20 or > 70 years

- Anemia (serum hemoglobin level < 10 g/dL)

- Severe systemic disease

- Advanced chronic liver disease

- Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics

- History of H. pylori eradication

- History of gastric surgery

- Recent history of upper gastrointestinal bleeding

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Digestive Disease Center, Soonchunhyang University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum pepsinogen change after H. pylori eradication Serum pepsinogen recovery after 8 weeks
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