Pattern of Upper Gastrointestinal LesionsNCT04328324
Pattern of Upper Gastrointestinal Lesions in Upper Egypt : Clinical, Endoscopic and Pathological Evaluation
An observational study of Pattern of Upper Gastrointestinal Lesions, run by Assiut University.
Trial summary
Upper Gastrointestinal (UGI) symptoms are among the commonest complaints for which patients seek medical attention, with the annual prevalence of dyspepsia approximating 25% . Endoscopy holds an important place in the diagnosis of UGI conditions by enabling visualization, photography, ultrasonography, and biopsying of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pattern of Upper Gastrointestinal Lesions
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2020to 30 Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient undergoing elective and urgent upper GIT endoscopy either therapeutic or diagnostic. In elrajhi endoscopy unit
Who may be able to join
- All patient undergoing elective and urgent upper GIT endoscopy either therapeutic or diagnostic.
Who cannot join
- Patient undergoing endoscopic intervention for previously detected endoscopic lesion
About this study
Upper Gastrointestinal (UGI) symptoms are among the commonest complaints for which patients seek medical attention, with the annual prevalence of dyspepsia approximating 25% . Endoscopy holds an important place in the diagnosis of UGI conditions by enabling visualization, photography, ultrasonography, and biopsying of suspicious lesions . It gives a better diagnostic yield over radiology particularly in the investigation of upper gastrointestinal bleeding, inflammatory conditions of the upper gastro-intestinal track like esophagitis, gastritis and duodenitis as well as the diagnosis of Mallory Weiss tears and vascular malformations .Dyspepsia in the absence of any other symptom was the indication for UGIE in the vast majority of patients. Close to 80% of our patients presented with dyspepsia not associated with any other symptom and in 50% of the patients the endoscopic findings were normal [4]. Other common reasons for UGIE were GERD symptoms, recurrent vomiting, dyspepsia associated with weight loss and patients with symptoms of UGI bleeding . Gastritis was the most frequent endoscopic finding in our patients, followed by duodenitis .Gastric ulcer was diagnosed more frequently than duodenal ulcers . Taking a biopsy is very helpful in diagnosis in our study. H. pylori colonization of the gut is the main cause of chronic gastritis and the principal etiological agent of gastric cancer and peptic ulcer disease . Gastric cancer was diagnosed, by endoscopy, about eight times more frequently in patients presenting with an alarm symptom like recurrent vomiting, dyspepsia together with weight loss or UGI bleeding .
- Being tested
- Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Diagnostic upper Git endoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of upper gastrointestinal lesions
We will see what common GIT lesions happen in patients of upper Egypt
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 posted31 Mar 2020
- Study start30 Mar 2020 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pattern of Upper Gastrointestinal LesionsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Hussein Mohammed Hasanen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328324
- Sponsor's protocol ID
- 2832020
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Upper Gastrointestinal Lesions in Upper Egypt : Clinical, Endoscopic and Pathological Evaluation
- ClinicalTrials.gov ID
- NCT04328324
- Acronym / sponsor ID
- 2832020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 31 Mar 2020 (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.
Upper Gastrointestinal (UGI) symptoms are among the commonest complaints for which patients seek medical attention, with the annual prevalence of dyspepsia approximating 25% . Endoscopy holds an important place in the diagnosis of UGI conditions by enabling visualization, photography, ultrasonography, and biopsying of suspicious lesions . It gives a better diagnostic yield over radiology particularly in the investigation of upper gastrointestinal bleeding, inflammatory conditions of the upper gastro-intestinal track like esophagitis, gastritis and duodenitis as well as the diagnosis of Mallory Weiss tears and vascular malformations .Dyspepsia in the absence of any other symptom was the indication for UGIE in the vast majority of patients. Close to 80% of our patients presented with dyspepsia not associated with any other symptom and in 50% of the patients the endoscopic findings were normal [4]. Other common reasons for UGIE were GERD symptoms, recurrent vomiting, dyspepsia associated with weight loss and patients with symptoms of UGI bleeding . Gastritis was the most frequent endoscopic finding in our patients, followed by duodenitis .Gastric ulcer was diagnosed more frequently than duodenal ulcers . Taking a biopsy is very helpful in diagnosis in our study. H. pylori colonization of the gut is the main cause of chronic gastritis and the principal etiological agent of gastric cancer and peptic ulcer disease . Gastric cancer was diagnosed, by endoscopy, about eight times more frequently in patients presenting with an alarm symptom like recurrent vomiting, dyspepsia together with weight loss or UGI bleeding .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient undergoing elective and urgent upper GIT endoscopy either therapeutic or diagnostic. In elrajhi endoscopy unit
Key inclusion criteria (1 listed)
- All patient undergoing elective and urgent upper GIT endoscopy either therapeutic or diagnostic.
Key exclusion criteria (1 listed)
- Patient undergoing endoscopic intervention for previously detected endoscopic lesion
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 |
|---|---|---|
| EndoscopyDiagnostic upper Git endoscopy | Procedure or surgery | – |
Primary outcome
Pattern of upper gastrointestinal lesions
Time frame: 1 year
We will see what common GIT lesions happen in patients of upper Egypt
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pattern of Upper Gastrointestinal Lesions, run by Assiut 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. 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?
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?
Pattern of 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 31 Mar 2020.