Adverse Events During Upper Gastrointestinal Endoscopy

Gastric Cancer Clinical Trial

— AEDUGESSH  

Official title:

Adverse Events During Upper Gastrointestinal Endoscopy With and Without Sedation: a Multiple Center Report From Shanghai

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01979549
• Other study ID #: AEDUGESSH
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2013
• Last updated: January 20, 2014
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: RenJi Hospital
• Contact: Diansan Su, Doctor
• Phone: 0086-21-68383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients will undergo upper gastrointestinal endoscopy

• Age > 18 years old

• Signed informed consent form

Exclusion Criteria:

• Pregnant

• Allergy to propofol or soybean or albumen

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophagitis
• Esophagus Cancer
• Gastric Cancer
• Oesophagitis
• Patients Need Upper Gastrointestinal Endoscopy
• Peptic Ulcer

Locations

Country	Name	City	State
China	Renji hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Investigate the adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy with and without sedation.	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	No