The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: H pylori eradication

• Registration Number: NCT02682446
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

After endoscopic resection of early gastric cancer (EGC), there remained concerned about the development of the metachronous gastric neoplasm (MGN). The aim of this study was to evaluate the role of H. pylori eradication for reducing MGN after ESD and the efficacy of serum pepsinogen (PG) for predicting development of MGN after endoscopic submucosal dissection (ESD) for EGC and to evaluate other risk factors for the incidence of MGN. The investigators enrolled the participants who were tested serum PG I and II at the time of ESD for EGC, from January 2007 to May 2013 in single tertiary center, retrospectively. The baseline characteristics of the participants, H. pylori status, and serum pepsinogen were analyzed for the development of the MGN.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-10
• Last Update Submitted: 2016-02-10
• Study First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• The patients who tested serum PG concentration test and H. pylori status at the time of ESD and revealed pathologically complete en bloc resection after ESD for EGC.

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Exclusion Criteria

• previous history of ER; proven pathologically incomplete resection or lympho-vascular invasion on the resected ESD specimen; additional treatment after ESD; and follow-up loss less than 2 years.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persistent H. pylori group	H pylori eradication	The participants revealed to fail in H. pylori eradication in those who were positive findings of H pylori IgG and other invasive methods (rapid urease test or histology) at the time of ESD for EGC
Eradicated H. pylori group	H pylori eradication	The participants revealed to success for H. pylori eradication in those who were positive findings of H pylori IgG and other invasive methods (rapid urease test or histology) at the time of ESD for EGC

Primary Outcome Measures

Name	Time	Method
To estimate the incidence (number of participants) of metachronous gastric neoplasm after ESD between H. pylori eradicated group and H. pylori persistent group	Up to 8 years after ESD for EGC	The investigators were estimated the number of participants who found metachronous gastric neoplasm after ESD for EGC during follow up endoscopic surveillance. Then, the investigator will evaluate the statitistical difference in the incidence of the development of metachornous gastric neoplasm between H. pylori eradicated group and H. pylori persistent group.

Secondary Outcome Measures

Name	Time	Method
To evaluate the incidence of metachronous gastric neoplasm after ESD based on diffferent cut off point of serum pepsinogen.	Up to 8 years after ESD for EGC	The investigators will evaluate the incidence of metachronous gastric neoplasm after ESD using several cut off level of serum pepsinogen: 30, 50 and 70 ng/mL for PG I and 3 for PG I/II ratio. The appropriate cut off level could be found for indicating the development of metachronous gastric neoplasm using serum PG