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

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02090062
• Other study ID #: rjxhnk2014
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2014
• Last updated: March 17, 2014
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Xiaobo Li, MD.Ph.D
• Phone: 86-21-58752345
• Email: lxb_1969[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Gastric Cancer
• Helicobacter Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in H. pylori infection rate before and after ER	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.	in two weeks after endoscopic resection	No