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出境医 / 临床实验 / Serum Pepsinogen After H. Pylori Eradication

Serum Pepsinogen After H. Pylori Eradication

Study Description
Brief 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.

Condition or disease
Helicobacter Pylori Eradication

Detailed Description:
This study aimed to evaluate the change of serum PGs after H. pylori eradication success and identify the optimal timing of eradication.
Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Serum Pepsinogen After Helicobacter Pylori Eradication for the Gastric Cancer Prevention
Actual Study Start Date : March 15, 2019
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : May 31, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Serum pepsinogen change after H. pylori eradication [ Time Frame: after 8 weeks ]
    Serum pepsinogen recovery


Biospecimen Retention:   Samples Without DNA
Biospecimen would be obtained for urease test (commercial name: CLOtest).

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
H. pylori-infected subjects who underwent an upper gastrointestinal endoscopy were enrolled in this study at a single, tertiary-care, academic medical center.
Criteria

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
Contacts and Locations

Locations
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Korea, Republic of
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, Korea, Republic of, 04401
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Principal Investigator: Jun-Hyung Jun-Hyung, M.D. Digestive Disease Center, Soonchunhyang University Hospital
Tracking Information
First Submitted Date April 20, 2019
First Posted Date April 23, 2019
Last Update Posted Date July 27, 2020
Actual Study Start Date March 15, 2019
Actual Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2019) 		Serum pepsinogen change after H. pylori eradication [ Time Frame: after 8 weeks ]
Serum pepsinogen recovery
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serum Pepsinogen After H. Pylori Eradication
Official Title Serum Pepsinogen After Helicobacter Pylori Eradication for the Gastric Cancer Prevention
Brief 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.
Detailed Description This study aimed to evaluate the change of serum PGs after H. pylori eradication success and identify the optimal timing of eradication.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Biospecimen would be obtained for urease test (commercial name: CLOtest).
Sampling Method Non-Probability Sample
Study Population H. pylori-infected subjects who underwent an upper gastrointestinal endoscopy were enrolled in this study at a single, tertiary-care, academic medical center.
Condition Helicobacter Pylori Eradication
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 20, 2019) 		100
Original Estimated Enrollment Same as current
Actual Study Completion Date May 31, 2020
Actual Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03924375
Other Study ID Numbers SCH-HP-2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jun-Hyung Cho, Soonchunhyang University Hospital
Study Sponsor Soonchunhyang University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jun-Hyung Jun-Hyung, M.D. Digestive Disease Center, Soonchunhyang University Hospital
PRS Account Soonchunhyang University Hospital
Verification Date July 2020

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