Digestive System AbnormalitiesNCT03603093
A Multicenter Survey of the Indications for Esophagogastroduodenoscopy (EGD)
An observational study of Digestive System Abnormalities and Endoscopy, run by Children's Hospital of Fudan University at 1 site in China.
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 through this multicenter study. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Digestive System Abnormalities, Endoscopy
- How many people
- 2,287 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2018to 30 Oct 2019
- 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
- Patients whose parents reject to provide information for study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Children's Hospital of Fudan University
Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. The investigators want to find which symptoms can support for positive endoscopic findings through this multicenter study.
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, Endoscopy
- Keywords
- Esophagogastroduodenoscopy, Paediatric
- Medical subject headings
- Digestive System Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantities of every indications for esophagogastroduodenoscopic procedures collected from questionaire finished by clinical doctor
Indications for esophagogastroduodenoscopic procedures were collected through questionaire, including abdominal pain, vomiting, and so on.
Measured: from August 15th to October 15th in 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start24 Dec 2018
- Primary completion30 Aug 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Children's Hospital, Wuhan Children's Hospital, Xiamen Children's Hospital, Henan Provincial People's Hospital
- 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
- NCT03603093
- Sponsor's protocol ID
- fudanU-E2
- Status last verified
- Nov 2021
- First submitted
- 18 Jul 2018
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang S, Qiu X, Chen J, Mei H, Yan H, You J, Huang Y. Pediatric esophagogastroduodenoscopy in china: indications, diagnostic yield, and factors associated with findings. BMC Pediatr. 2022 Sep 2;22(1):522. doi: 10.1186/s12887-022-03558-x.
PubMed 36056317
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Hospital of Fudan University
- ClinicalTrials.gov ID
- NCT03603093
- Acronym / sponsor ID
- fudanU-E2
- Conditions
- Digestive System Abnormalities, Endoscopy
- Keywords
- Esophagogastroduodenoscopy, Paediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,287 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Hunan Children's Hospital, Wuhan Children's Hospital, Xiamen Children's Hospital, Henan Provincial People's Hospital
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- 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 through this multicenter study.
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
- Cohort
- Time perspective
- Cross-sectional
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)
- Patients whose parents reject to provide information for study
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
Quantities of every indications for esophagogastroduodenoscopic procedures collected from questionaire finished by clinical doctor
Time frame: from August 15th to October 15th in 2018
Indications for esophagogastroduodenoscopic procedures were collected through questionaire, including abdominal pain, vomiting, and so on.
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 18 Nov 2021.
- Derived from this study: PubMed 36056317Wang S, Qiu X, Chen J, Mei H, Yan H, You J, Huang Y. Pediatric esophagogastroduodenoscopy in china: indications, diagnostic yield, and factors associated with findings. BMC Pediatr. 2022 Sep 2;22(1):522. doi: 10.1186/s12887-022-03558-x.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive System Abnormalities and Endoscopy, run by Children's Hospital of Fudan University at 1 site 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 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 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Quantities of every indications for esophagogastroduodenoscopic procedures collected from questionaire finished by clinical doctor (time frame: from August 15th to October 15th in 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603093, which also lists 1 linked publication.
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 18 Nov 2021.