Clinical trial NCT02682446: The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm
Official title: Prediction for the Development of Metachronous Gastric Cancer After Endoscopic Submucosal Dissection by Serum Pepsinogen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Early gastric cancer
endoscopic submucosal dissection
serum pepsinogen
Helicobacter pylori
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was designed to enroll patients in our ESD data registry, prospectively. Finally, we analyzed the data retrospectively. We enrolled about more than 1000 patients in our ESD registry. For this cohort study, we enrolled about 800 patients for analysis.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To estimate the incidence (number of participants) of metachronous gastric neoplasm after ESD between H. pylori eradicated group and H. pylori persistent group
timeFrame: Up to 8 years after ESD for EGC
Secondary outcomes:
measure: To evaluate the incidence of metachronous gastric neoplasm after ESD based on diffferent cut off point of serum pepsinogen.
timeFrame: Up to 8 years after ESD for EGC
Other outcomes:
Locations:
Study officials:
affiliation: Gastric cancer center, Kyungpook national university medical center
name: Seong Woo Jeon, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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