The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

H pylori eradication

Drug

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]

Primary outcomes

To estimate the incidence (number of participants) of metachronous gastric neoplasm after ESD between H. pylori eradicated group and H. pylori persistent group

Time frame: 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 outcomes

To evaluate the incidence of metachronous gastric neoplasm after ESD based on diffferent cut off point of serum pepsinogen.

Time frame: 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

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2015
Study completion: 2015
First posted: Feb 15, 2016
Registry last updated: Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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