Clinical trial · Observational

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

NCT02682446CI-TRIAL-00020910completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
H pylori eradication	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

label
Negative H. pylori group
description
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
label
Previous H. pylori infection group
description
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
label
Eradicated H. pylori group
description
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
interventionNames
1. Drug: H pylori eradication
label
Persistent H. pylori group
description
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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 85 Years

Show eligibility criteria text

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.

References

Publications (8)

RESULTFukase 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 gastric cancer: an open-label, randomised controlled trial. Lancet. 2008 Aug 2;372(9636):392-7. doi: 10.1016/S0140-6736(08)61159-9. PMID 18675689
RESULTAbe 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. Endoscopy. 2015 Dec;47(12):1113-8. doi: 10.1055/s-0034-1392484. Epub 2015 Jul 10. PMID 26165734
RESULTChoi KS, Jung HY, Choi KD, Lee GH, Song HJ, Kim DH, 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):942-8. doi: 10.1016/j.gie.2010.12.032. Epub 2011 Mar 9. PMID 21392757
RESULTSuzuki 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 metachronous gastric cancer risk. J Gastroenterol. 2014 Jul;49(7):1135-44. doi: 10.1007/s00535-013-0861-7. Epub 2013 Aug 13. PMID 23942619
RESULTBae SE, Jung HY, Kang J, Park YS, Baek S, Jung JH, Choi JY, Kim MY, Ahn JY, Choi KS, Kim DH, Lee JH, Choi KD, Song HJ, Lee GH, Kim JH. Effect of Helicobacter pylori eradication on metachronous recurrence after endoscopic resection of gastric neoplasm. Am J Gastroenterol. 2014 Jan;109(1):60-7. doi: 10.1038/ajg.2013.404. Epub 2013 Dec 17. PMID 24343545
RESULTSamloff 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. No abstract available.