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The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm

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ClinicalTrials.gov Identifier: NCT02682446
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Seong Woo Jeon, 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.

Condition or disease Intervention/treatment
Gastric Cancer Drug: H pylori eradication

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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction for the Development of Metachronous Gastric Cancer After Endoscopic Submucosal Dissection by Serum Pepsinogen
Study Start Date : January 2007
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort Intervention/treatment
Negative H. pylori group
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
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
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
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]

Persistent H. pylori group
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
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 Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
Serum pepsinogen, serum HP IgG


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682446


Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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Principal Investigator: Seong Woo Jeon, Prof. Gastric cancer center, Kyungpook national university medical center
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seong Woo Jeon, Professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT02682446    
Other Study ID Numbers: KNUMC_13-1059
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Seong Woo Jeon, Kyungpook National University Hospital:
Early gastric cancer
endoscopic submucosal dissection
serum pepsinogen
Helicobacter pylori
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases