The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm

Study Overview
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Brief Summary
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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.

Official Title
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Prediction for the Development of Metachronous Gastric Cancer After Endoscopic Submucosal Dissection by Serum Pepsinogen

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: H pylori eradication


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Negative H. pylori group<br>The participants revealed negative findings of H pylori IgG and other invasive methods (rapid urease test or histology) at the time of ESD for EGC | |
| Previous H. pylori infection group<br>The participants revealed 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<br>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 | Drug: H pylori eradication<br>* The regimen of H. pylori eradication was like that: 1-week conventional proton pump inhibitor (PPI) based triple therapy (lansoprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for a week) after confirmation of H. pylori infection. If the participants who initially failed to respond to the first eradication, they recommended to underwent second-line eradication therapy with the regimen of 7-day bismuth containing quadruple regimen [lansoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate (Denol; Greencross Co., Seoul, Korea) 300 mg q.i.d. (three tablets 30 min before meals and one tablet 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d. for 1 week]<br>|
| Persistent H. pylori group<br>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 | Drug: H pylori eradication<br>* The regimen of H. pylori eradication was like that: 1-week conventional proton pump inhibitor (PPI) based triple therapy (lansoprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for a week) after confirmation of H. pylori infection. If the participants who initially failed to respond to the first eradication, they recommended to underwent second-line eradication therapy with the regimen of 7-day bismuth containing quadruple regimen [lansoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate (Denol; Greencross Co., Seoul, Korea) 300 mg q.i.d. (three tablets 30 min before meals and one tablet 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d. for 1 week]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the incidence (number of participants) of metachronous gastric neoplasm after ESD between H. pylori eradicated group and H. pylori persistent group | 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. | Up to 8 years after ESD for EGC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the incidence of metachronous gastric neoplasm after ESD based on diffferent cut off point of serum pepsinogen. | 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 | Up to 8 years after ESD for EGC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early gastric cancer, endoscopic submucosal dissection, serum pepsinogen, Helicobacter pylori