Digestive System AbnormalitiesNCT02789514
A Survey of the Indications for Esophagogastroduodenoscopy (EGD) in Children's Hospital of Fudan University
An observational study of Digestive System Abnormalities, run by Children's Hospital of Fudan University.
Trial summary
Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. The investigators want to find which symptoms can support for positive endoscopic findings. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Digestive System Abnormalities
- How many people
- 1,303 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Oct 2016
- 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All of the patients need esophagogastroduodenoscopic procedures
Who may be able to join
- All of the patients need esophagogastroduodenoscopic procedures
Who cannot join
- None
About this study
Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. The investigators want to find which symptoms can support for positive endoscopic findings.
Read the detailed description
Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. And there are indications for EGD. Here, investigators want to find which symptoms can strongly support for positive endoscopy findings. So, investigators design the study to record the symptoms in detail and diagnosis, and then analysis symptoms and the rate of endoscopic findings.
- Conditions
- Digestive System Abnormalities
- Keywords
- esophagogastroduodenoscopy, paediatric
- Medical subject headings
- Digestive System Abnormalities
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 |
|---|---|---|
| children | Investigators give observation to the patients who need esophagogastroduodenoscopic procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires about the indications for esophagogastroduodenoscopic procedures were collected
The content of questionnaire include the symptoms which prompt for the esophagogastroduodenoscopic procedure, and the diagnosis. Then investigators will analysis the relationship between symptom and diagnosis.
Measured: May, 2016-August, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
- Investigators
- Ying Huang, doctor, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789514
- Sponsor's protocol ID
- fudanU-E1
- Status last verified
- Feb 2017
- First submitted
- 19 May 2016
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of the Indications for Esophagogastroduodenoscopy (EGD) in Children's Hospital of Fudan University
- ClinicalTrials.gov ID
- NCT02789514
- Acronym / sponsor ID
- fudanU-E1
- Conditions
- Digestive System Abnormalities
- Keywords
- esophagogastroduodenoscopy, paediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,303 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Jun 2016 (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.
Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. The investigators want to find which symptoms can support for positive endoscopic findings.
Detailed description
Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. And there are indications for EGD. Here, investigators want to find which symptoms can strongly support for positive endoscopy findings. So, investigators design the study to record the symptoms in detail and diagnosis, and then analysis symptoms and the rate of endoscopic findings.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children | – | –Investigators give observation to the patients who need esophagogastroduodenoscopic procedures. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All of the patients need esophagogastroduodenoscopic procedures
Key inclusion criteria (1 listed)
- All of the patients need esophagogastroduodenoscopic procedures
Key exclusion criteria (1 listed)
- None
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
Questionnaires about the indications for esophagogastroduodenoscopic procedures were collected
Time frame: May, 2016-August, 2016
The content of questionnaire include the symptoms which prompt for the esophagogastroduodenoscopic procedure, and the diagnosis. Then investigators will analysis the relationship between symptom and diagnosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ying Huang, doctor study director
Children's Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive System Abnormalities, run by Children's Hospital of Fudan University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaires about the indications for esophagogastroduodenoscopic procedures were collected (time frame: May, 2016-August, 2016). 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 6 Feb 2017.