Patients Need Upper Gastrointestinal EndoscopyAEDUGESSHNCT01979549
Adverse Events During Upper Gastrointestinal Endoscopy
An observational study of Patients Need Upper Gastrointestinal Endoscopy and Peptic Ulcer, run by RenJi Hospital at 3 sites in China.
Trial summary
The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Need Upper Gastrointestinal Endoscopy, Peptic Ulcer, Gastric Cancer
- How many people
- 6,000 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo the upper gastrointestinal endoscopy
Who may be able to join
- Patients will undergo upper gastrointestinal endoscopy
- Age > 18 years old
- Signed informed consent form
Who cannot join
- Pregnant
- Allergy to propofol or soybean or albumen
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Xiaoqing Zhang, M.S., xq_820175@163.com
Xiaoqing Zhang, M.S.
- Recruiting
Renji hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Diansan Su, Doctor, 0086-21-68383702, diansansu@yahoo.com
Diansan Su, Doctor
- Recruiting
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality
lizhi Li, M.S., Fmlilizhi@sina.com.cn
Lizhi Li, M.S.
About this study
Official title: Adverse Events During Upper Gastrointestinal Endoscopy With and Without Sedation: a Multiple Center Report From Shanghai
The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population
- Conditions
- Patients Need Upper Gastrointestinal Endoscopy, Peptic Ulcer, Gastric Cancer, Esophagus Cancer, Oesophagitis
- Keywords
- Adverse events, Upper gastrointestinal endoscopy, Sedation
- Medical subject headings
- Peptic Ulcer, Stomach Neoplasms, Esophageal Neoplasms, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sedation | patients underwent upper gastrointestinal endoscopy with sedation | |
| non-sedation | patients underwent upper gastrointestinal endoscopy without sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Need Upper Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
- Investigators
- Diansan Su, Doctor, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979549
- Sponsor's protocol ID
- AEDUGESSH
- Acronym
- AEDUGESSH
- Status last verified
- Dec 2013
- First submitted
- 3 Nov 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Events During Upper Gastrointestinal Endoscopy With and Without Sedation: a Multiple Center Report From Shanghai
- ClinicalTrials.gov ID
- NCT01979549
- Acronym / sponsor ID
- AEDUGESSH / AEDUGESSH
- Conditions
- Patients Need Upper Gastrointestinal Endoscopy, Peptic Ulcer, Gastric Cancer, Esophagus Cancer, Oesophagitis
- Keywords
- Adverse events, Upper gastrointestinal endoscopy, Sedation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation | – | –patients underwent upper gastrointestinal endoscopy with sedation |
| non-sedation | – | –patients underwent upper gastrointestinal endoscopy without sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo the upper gastrointestinal endoscopy
Key inclusion criteria (3 listed)
- Patients will undergo upper gastrointestinal endoscopy
- Age > 18 years old
- Signed informed consent form
Key exclusion criteria (2 listed)
- Pregnant
- Allergy to propofol or soybean or albumen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse events
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diansan Su, Doctor principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Need Upper Gastrointestinal Endoscopy and Peptic Ulcer, run by RenJi Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Doctor (0086-21-68383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.