The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682446
• Other study ID #: KNUMC_13-1059
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: February 10, 2016
• Start date: January 2007
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

References & Publications (7)

Abe S, Oda I, Suzuki H, Nonaka S, Yoshinaga S, Nakajima T, Sekiguchi M, Mori G, Taniguchi H, Sekine S, Katai H, Saito Y. Long-term surveillance and treatment outcomes of metachronous gastric cancer occurring after curative endoscopic submucosal dissection — View Citation

Bae SE, Jung HY, Kang J, Park YS, Baek S, Jung JH, Choi JY, Kim MY, Ahn JY, Choi KS, Kim do H, Lee JH, Choi KD, Song HJ, Lee GH, Kim JH. Effect of Helicobacter pylori eradication on metachronous recurrence after endoscopic resection of gastric neoplasm. A — View Citation

Choi KS, Jung HY, Choi KD, Lee GH, Song HJ, Kim do H, Lee JH, Kim MY, Kim BS, Oh ST, Yook JH, Jang SJ, Yun SC, Kim SO, Kim JH. EMR versus gastrectomy for intramucosal gastric cancer: comparison of long-term outcomes. Gastrointest Endosc. 2011 May;73(5):94 — View Citation

Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group. Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastr — View Citation

Samloff IM, Varis K, Ihamaki T, Siurala M, Rotter JI. Relationships among serum pepsinogen I, serum pepsinogen II, and gastric mucosal histology. A study in relatives of patients with pernicious anemia. Gastroenterology. 1982 Jul;83(1 Pt 2):204-9. — View Citation

Suzuki R, Yamamoto E, Nojima M, Maruyama R, Yamano HO, Yoshikawa K, Kimura T, Harada T, Ashida M, Niinuma T, Sato A, Nosho K, Yamamoto H, Kai M, Sugai T, Imai K, Suzuki H, Shinomura Y. Aberrant methylation of microRNA-34b/c is a predictive marker of metac — View Citation

Watabe H, Mitsushima T, Yamaji Y, Okamoto M, Wada R, Kokubo T, Doi H, Yoshida H, Kawabe T, Omata M. Predicting the development of gastric cancer from combining Helicobacter pylori antibodies and serum pepsinogen status: a prospective endoscopic cohort stu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No