Correlation of Endoscopic Findings and Symptoms in Patien... | NCT03736824

Studies
Correlation of Endoscopic Findings and Symptoms in Patients Undergoing the First Upper Gastrointestinal Endoscopy

NCT03736824

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Nov 9, 2018Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Symptoms and Signs
Malignancy
Ulcer Peptic

Interventions

endoscopy

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 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Nov 30, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Nov 8, 2018

First Submission Date that Met QC Criteria

Nov 8, 2018

First Posted Date

Nov 9, 2018Actual

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 8, 2018

Last Update Posted Date

Nov 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, 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

Endoscopy is the best means of finding early stage of upper gastrointestinal diseases, especially early cancer and benign ulcers. Currently, most people still undergo upper gastrointestinal endoscopy due to discomfort, rather than a regular physical examination at a certain age. This study prospectively investigated the reason for undergoing the first upper gastrointestinal endoscopy in patients and found the correlation of endoscopic findings and symptoms.

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

5,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endoscopy	Procedure	All endoscopy was performed by qualified gastroenterologists or endoscopic physicians in Renji hospital,Shanghai Jiaotong University School of Medicine.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of endoscopic findings and symptoms	survey	Within two weeks after receiving the survey

Secondary Outcomes

Measure	Description	Time Frame
The proportion of various symptoms in patients undergoing the first upper gastrointestinal endoscopy		Within two weeks after receiving the survey
The proportion of different upper gastrointestinal diseases	Diagnosis of upper gastrointestinal disease combined with endoscopic findings and pathological diagnosis.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing the first upper gastrointestinal endoscopy.

Exclusion Criteria:

The patients had previously performed endoscopy and any esophageal, gastric or duodenal surgery.
The patients couldn't complete the questionnaire survey under the guidance of physicians at the appointment of the upper gastrointestinal endoscopy.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing the first upper gastrointestinal endoscopy were collected from January 2018 to December 2018 in Renji Hospital, Shanghai Jiaotong University School of Medicine.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huiyi Li	Contact	+8613761902402		lhy177279@163.com

Overall Officials

Name	Affiliation	Role
Hong Lu	School of Medicine, Shanghai Jiao Tong University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, Shanghai Jiaotong University School of Medicine	Recruiting	Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012816	Signs and Symptoms
D009369	Neoplasms
D010437	Peptic Ulcer

Ancestor Terms

ID	Term
D013568	Pathological Conditions, Signs and Symptoms
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided