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

NCT02090062 | Unknown

• 1 other identifier: rjxhnk2014
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Early Gastric Cancer

Keywords

endoscopic resection; H. pylori infection

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with early gastric lesions

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

All the lesions will be removed endoscopically or surgically and examine histologically by an independent gastrointestinal pathologist. Each biospecimen after ER will be detected H pylori infection status.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xiaobo Li, MD.Ph.D

  Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaobo Li, MD.Ph.D

CONTACT

86-21-58752345; lxb_1969@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 18, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 19, 2014

Record last verified: 2014-03