- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02090062
Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection
March 17, 2014 updated by: Xiaobo Li, Shanghai Jiao Tong University School of Medicine
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaobo Li, MD.Ph.D
- Phone Number: 86-21-58752345
- Email: lxb_1969@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with early gastric lesions
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
in two weeks after endoscopic resection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
March 13, 2014
First Submitted That Met QC Criteria
March 15, 2014
First Posted (Estimate)
March 18, 2014
Study Record Updates
Last Update Posted (Estimate)
March 19, 2014
Last Update Submitted That Met QC Criteria
March 17, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- rjxhnk2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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