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Clinical Trials/NCT02090062
NCT02090062UnknownNot Applicable

Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection

Shanghai Jiao Tong University School of Medicine0 sites60 target enrollmentStarted: March 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Primary Endpoint
difference in H. pylori infection rate before and after ER

Study Overview

Brief Summary

Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study aims to determine the difference in H. pylori infection rate of EGC patients before and after ER , and discuss the causes leading to the difference, which can provide references for improving the diagnostic accuracy of H. pylori infection and reducing EGC's recurrence rate.

Detailed Description

Gastric cancer is the fourth most commonly diagnosed cancer in the world and the second leading cause of cancer-related deaths. Nowadays, endoscopic resection(ER) is widely accepted as the primary treatment for early gastric cancer (EGC) without lymph node metastasis,which includes endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).However, recurrence rate after endoscopic resection for EGC still achieves 6.7%-14%. However, there is no comparative analysis about H. pylori infection rate before and after ER yet.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •high grade dysplasia(HGD) and EGC patients treated by endoscopic resection(including EMR and ESD) in Ren Ji hospital

Exclusion Criteria

  • •Suspect of advanced gastric cancer
  • •Lesions with light grade dysplasia
  • •History of gastric surgery
  • •Poor gastrointestinal preparation
  • •Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc

Outcomes

Primary Outcomes

difference in H. pylori infection rate before and after ER

Time Frame: in two weeks after endoscopic resection

Information on the H pylori infection status before ER will be collected from the medical records of each patient. A positive result on at least one rapid urease test, urease breath test or Giemsa staining is deemed to be indicative of H pylori infection .Each specimen after ER will be detected H pylori infection status in two weeks. Then we analyze the difference in H. pylori infection rate before and after ER.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiaobo Li

Shanghai Institute of Digestive Disease,Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai Jiao Tong University School of Medicine

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