The Prevalence of Helicobacter Pylori in Shanghai, 2013 to 2019

• Sponsor: Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04636866
• Collaborator: (none)
• Enrollment: 400,000
• Location: 1
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 55593.6

Study Details

Study Description

Brief Summary

The study was a cross-sectional single-center study, conducted at Renji Hospital, Shanghai Jiaotong university school of medicine. We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy from January 1, 2013 through December 31, 2019. The medical records were analyzed for the prevalence of H. pylori infection in patients with peptic ulcers.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer; Helicobacter Pylori Infection	Other: NO intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 400000 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: The Prevalence of Helicobacter Pylori Infection in Patients With Peptic Ulcer Disease in Shanghai, 2013 to 2019
• Actual Study Start Date: Feb 10, 2020
• Actual Primary Completion Date: Jul 21, 2020
• Actual Study Completion Date: Sep 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Gastric ulcer	Other: NO intervention; NO intervention
Duodenal ulcer	Other: NO intervention; NO intervention

Outcome Measures

Primary Outcome Measures

1. the prevalence of Helicobacter pylori and peptic ulcer [2013.1.1-2019.12.31]

   the trends change from 2013 to 2019

2. the ration of Helicobacter pylori positive peptic ulcers [2013.1.1-2019.12.31]

   the trends change from 2013 to 2019

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All patients who had undergone upper gastrointestinal endoscopy in Renji Hospital because of uninvestigated dyspepsia during 2013 and 2019 were analyzed.

Exclusion Criteria:

Patients that underwent upper endoscopy for reasons other than uninvestigated dyspepsia such as cirrhosis follow-up, major systemic diseases or other indications were excluded. Exclusions also included absence of biopsies, unknown H. pylori status and acute ulcer bleeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• Shanghai Jiao Tong University School of Medicine

Investigators

• Study Director: HONG LU, PhD, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hong Lu, MD, Doctor, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04636866
• Other Study ID Numbers: shrj202010171
• First Posted: Nov 19, 2020
• Last Update Posted: Nov 19, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Helicobacter Infections; Peptic Ulcer

Study Results

No Results Posted as of Nov 19, 2020