The Prevalence of Helicobacter Pylori in Shanghai, 2013 t... | NCT04636866

Studies
The Prevalence of Helicobacter Pylori in Shanghai, 2013 to 2019

NCT04636866

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Completed

Last Update Posted

Nov 19, 2020Actual

Enrollment

400,000Actual

Phase

Not provided

Conditions

Peptic Ulcer
Helicobacter Pylori Infection

Interventions

NO intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2020Actual

Primary Completion Date

Jul 21, 2020Actual

Completion Date

Sep 16, 2020Actual

First Submitted Date

Nov 14, 2020

First Submission Date that Met QC Criteria

Nov 14, 2020

First Posted Date

Nov 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2020

Last Update Posted Date

Nov 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Lu, MD, Doctor, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gastric ulcer			Other: NO intervention
Duodenal ulcer			Other: NO intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NO intervention	Other	NO intervention	Duodenal ulcer Gastric ulcer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the prevalence of Helicobacter pylori and peptic ulcer	the trends change from 2013 to 2019	2013.1.1-2019.12.31
the ration of Helicobacter pylori positive peptic ulcers	the trends change from 2013 to 2019	2013.1.1-2019.12.31

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy because of uninvestigated dyspepsia from January 1, 2013 through December 31, 2019.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HONG LU, PhD	RenJi Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, School of Medicine, Shanghai Jiao Tong University		Shanghai	Shanghai Municipality	200127	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010437	Peptic Ulcer

Ancestor Terms

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided