Upper Gastrointestinal LesionsNCT03524144
Upper Gastrointestinal Lesions in Crohn's Disease
A study testing gastroscopy in people with Upper Gastrointestinal Lesions and Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
A cross-sectional study was performed from 2017 to 2018. Consecutive Crohn's disease patients diagnosed in the Inflammatory bowel disease center of the Sixth Affiliated Hospital of Sun Yat-sen University were recruited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Lesions, Crohn's Disease
- What is being tested?
- gastroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 30 May 2018
- Phase
- Interventional
- 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
Who may be able to join
- Age is 18 years old or older
- patients with diagnosis of Crohn's disease
Who cannot join
- diagnostic data were incomplete
- patients with malignant tumor
- use of PPIs or non-steroidal anti-inflammatory drugs in the preceding 4 weeks
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: Upper Gastrointestinal Lesions in Crohn's Disease: a Cross-sectional Cohort Study
A cross-sectional study was performed from 2017 to 2018. Consecutive Crohn's disease patients diagnosed in the Inflammatory bowel disease center of the Sixth Affiliated Hospital of Sun Yat-sen University were recruited. All patients underwent upper gastrointestinal endoscopy and biopsy by two defined endoscopists and two pathologists, the basic information were collected at the same time, in order to assess the prevalence of upper gastrointestinal involvement, and determine the role of upper gastrointestinal endoscopy in adult Crohn's disease patients, irrespective of upper gastrointestinal symptoms.
- Conditions
- Upper Gastrointestinal Lesions, Crohn's Disease
- Being tested
- gastroscopy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastroscopyOther
Two endoscopists performed upper gastrointestinal endoscopy and biopsy on all patients; and histological review was performed by two pathologists. From each patient, 10 specimens were taken from 6 areas in the upper gastrointestinal tract and basic informations was collected.
| Study group | Role | What they receive |
|---|---|---|
| adult patients with Crohn's disease | Other | All adult patients(18 years old or older) with Crohn's disease underwent gastroscopy; patients with diagnosed and treated Crohn's disease had gastroscopy performed during the re-examination, and patients diagnosed with Crohn's disease for the first time had gastroscopy performed during the initial consultation. Receives: Other: gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of different upper gastrointestinal lesions
The incidence of different characteristic lesions of upper gastrointestinal in CD patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Jun 2017
- Primary completion30 May 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal LesionsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Xiang Gao, Study chair, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524144
- Sponsor's protocol ID
- 2017ZSLYEC-097
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 14 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Gastrointestinal Lesions in Crohn's Disease: a Cross-sectional Cohort Study
- ClinicalTrials.gov ID
- NCT03524144
- Acronym / sponsor ID
- 2017ZSLYEC-097
- Conditions
- Upper Gastrointestinal Lesions, Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 14 May 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.
A cross-sectional study was performed from 2017 to 2018. Consecutive Crohn's disease patients diagnosed in the Inflammatory bowel disease center of the Sixth Affiliated Hospital of Sun Yat-sen University were recruited. All patients underwent upper gastrointestinal endoscopy and biopsy by two defined endoscopists and two pathologists, the basic information were collected at the same time, in order to assess the prevalence of upper gastrointestinal involvement, and determine the role of upper gastrointestinal endoscopy in adult Crohn's disease patients, irrespective of upper gastrointestinal symptoms.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with Crohn's disease | Other | Other: gastroscopyAll adult patients(18 years old or older) with Crohn's disease underwent gastroscopy; patients with diagnosed and treated Crohn's disease had gastroscopy performed during the re-examination, and patients diagnosed with Crohn's disease for the first time had gastroscopy performed during the initial consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age is 18 years old or older
- patients with diagnosis of Crohn's disease
Key exclusion criteria (3 listed)
- diagnostic data were incomplete
- patients with malignant tumor
- use of PPIs or non-steroidal anti-inflammatory drugs in the preceding 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastroscopyTwo endoscopists performed upper gastrointestinal endoscopy and biopsy on all patients; and histological review was performed by two pathologists. From each patient, 10 specimens were taken from 6 areas in the upper gastrointestinal tract and basic informations was collected. | Other | adult patients with Crohn's disease |
Primary outcome
the incidence of different upper gastrointestinal lesions
Time frame: 1 year
The incidence of different characteristic lesions of upper gastrointestinal in CD patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
Related trials for Upper Gastrointestinal Lesions
Not yet recruitingObservational study
AI-Based Risk Prediction Model for Upper Digestive Tract Cancer
Gastric Cancer (GC), Premalignant Lesion
RecruitingObservational study
Establishment of Image Database for Early Upper Gastrointestinal Cancer, Precancerous Lesions, and Precancerous Conditions
Upper Gastrointestinal Cancer, Upper Gastrointestinal Precancerous Lesions
RecruitingObservational study
Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions
Insulinoma; Pancreas, MEN1
RecruitingPhase 2
Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy
Esophagogastroduodenoscopy, Simethicone
RecruitingObservational study
Endoscopic Resection of Gastrointestinal Neoplasms
Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection
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.
Xiang Gao study chair
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastroscopy in people with Upper Gastrointestinal Lesions and Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen 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 2 inclusion and 3 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 14 May 2018. 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?
Results are not available in the source record.
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?
the incidence of different upper gastrointestinal lesions (time frame: 1 year). 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 14 May 2018.