NCT02682446

The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	H pylori eradication	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 \[lansoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate (Denol; Greencross Co., Seoul, Korea) 300 mg q.i.d. (three tablets 30 min before meals and one tablet 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d. for 1 week\]

Timeline

• Start date: 2007-01-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2016-02-15
• Last updated: 2016-02-15