Upper Gastrointestinal DisorderNCT06092593
Upper Endoscopy in Ulcerative Colitis Patients in Assiut University
An observational study of Upper Gastrointestinal Disorder, run by Assiut University.
Trial summary
Aim of study: Primary Outcomes: Patients with ulcerative colitis-associated upper gas- trointestinal inflammation may require specific treat- ment for the gastroduodenal lesions. Hence, recogni- tion and detection of the upper gastrointestinal lesions are important. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Upper Gastrointestinal Disorder
- What is being tested?
- Upper endoscopy
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to Oct 2025
- 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 to 99 years
- All sexes
- Adult, Older adult
Study population: A cross sectionaql study will be conducted in Assuit University hospital .Adult patients diagnosed as UC by clinical date , laboratory ,colonscopy and histopathological examination will undergo : full medical history taking : age, gender, time since the ulcerative colitis diagnosis, History of surgery for ulcerative colitis, medications , history of any upper GIT symptoms nausea , vomiting , epigastric pain , heart burn , dysphagia and hematemsis or melena . complete physical examination , with focus on pulse, blood pressure, body temperature and signs of extra intestinal involvement. Esophagogastro-duodenoscopy Histopathological examination of biopsies taken from any lesions
Who may be able to join
- Patients' age is 18 years or above.
- Patient who are diagnosed with UC..
- Patient who are fit to undergo upper endoscopy .
Who cannot join
- Pediatric patients.
- patient refuse to participate at this study
- patient with known upper GIT disorder .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Upper Gastrointestinal Tract Lesions in Ulcerative Colitis Patients in Assiut University
Aim of study:
Primary Outcomes:
Patients with ulcerative colitis-associated upper gas- trointestinal inflammation may require specific treat- ment for the gastroduodenal lesions. Hence, recogni- tion and detection of the upper gastrointestinal lesions are important. Here we describe 2 cases of ulcerative colitis and summarize the results of our investigation of the prevalence of upper gastrointestinal involvement detected by esophagogastroduodenoscopy. We also analyzed the macroscopic and microscopic features of the upper gastrointestinal lesions
Secondary Outcomes:
correct and timely treatment of upprt GIT lesions in UC .
Read the detailed description
Ulcerative colitis (UC) is an idiopathic, chronic, relapsing inflammatory bowel disease (IBD) occurring in the colon and rectum . The main typical symptoms of UC include frequent bowel movement, mucus pus, bloody diarrhea, abdominal pain and discomfort, urgency, weight loss, and tenesmus . Apart from these typical symptoms, emerging evidence supports that there are a variety of accompanying symptoms involving the upper gastrointestinal (UGI) tract in patients with UC upon macroscopic and microscopic analyses, such as eosinophilic esophagitis[9], gastroduodenitis, ulcers, or UGI inflammation In addition, the positive rate of UGI endoscopy in asymptomatic individuals was lower than that in symptomatic patients. The reported clinically significant UGI lesions include multiple erosions, granular changes, white spots, friable mucosa, ulcer, and purulent deposits during fibrogastroduodenoscopy (FGDS)[ط UGI involvement may be unnoticed by the attending physician due to the lack of the knowledge of gastroduodenal lesions, which should raise concerns during UC treatment. Furthermore, there is no established standard or criteria available for patients with UC who should undergo FGDS , because the clinical backgrounds of these patients with UC-associated UGI lesions have not been fully and exactly demonstrated. Specific management may be required for patients with UC-associated UGI lesions. Henceforth, we conducted this study with the aim of describing various UGI tract presentations in UC and their differential diagnosis
- Conditions
- Upper Gastrointestinal Disorder
- Being tested
- Upper endoscopy
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper endoscopyDevice
Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients
The relationship between ulcerative colitis patients and upper gastrointestinal tract lesions
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal DisorderStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamal Abdelnasser Gaber Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092593
- Sponsor's protocol ID
- Upper endoscopy UC
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun Y, Zhang Z, Zheng CQ, Sang LX. Mucosal lesions of the upper gastrointestinal tract in patients with ulcerative colitis: A review. World J Gastroenterol. 2021 Jun 14;27(22):2963-2978. doi: 10.3748/wjg.v27.i22.2963.
PubMed 34168401Kato R, Iwamuro M, Hiraoka S, Takashima S, Inokuchi T, Takahara M, Kondo Y, Tanaka T, Okada H. Evaluation of the Upper Gastrointestinal Tract in Ulcerative Colitis Patients. Acta Med Okayama. 2018 Apr;72(2):105-113. doi: 10.18926/AMO/55850.
PubMed 29674758Queliza K, Ihekweazu FD, Schady D, Jensen C, Kellermayer R. Granulomatous Upper Gastrointestinal Inflammation in Pediatric Ulcerative Colitis. J Pediatr Gastroenterol Nutr. 2018 Apr;66(4):620-623. doi: 10.1097/MPG.0000000000001771.
PubMed 28991840
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Upper Gastrointestinal Tract Lesions in Ulcerative Colitis Patients in Assiut University
- ClinicalTrials.gov ID
- NCT06092593
- Acronym / sponsor ID
- Upper endoscopy UC
- Conditions
- Upper Gastrointestinal Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 23 Oct 2023 (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.
Aim of study:
Primary Outcomes:
Patients with ulcerative colitis-associated upper gas- trointestinal inflammation may require specific treat- ment for the gastroduodenal lesions. Hence, recogni- tion and detection of the upper gastrointestinal lesions are important. Here we describe 2 cases of ulcerative colitis and summarize the results of our investigation of the prevalence of upper gastrointestinal involvement detected by esophagogastroduodenoscopy. We also analyzed the macroscopic and microscopic features of the upper gastrointestinal lesions
Secondary Outcomes:
correct and timely treatment of upprt GIT lesions in UC .
Detailed description
Ulcerative colitis (UC) is an idiopathic, chronic, relapsing inflammatory bowel disease (IBD) occurring in the colon and rectum . The main typical symptoms of UC include frequent bowel movement, mucus pus, bloody diarrhea, abdominal pain and discomfort, urgency, weight loss, and tenesmus . Apart from these typical symptoms, emerging evidence supports that there are a variety of accompanying symptoms involving the upper gastrointestinal (UGI) tract in patients with UC upon macroscopic and microscopic analyses, such as eosinophilic esophagitis[9], gastroduodenitis, ulcers, or UGI inflammation In addition, the positive rate of UGI endoscopy in asymptomatic individuals was lower than that in symptomatic patients. The reported clinically significant UGI lesions include multiple erosions, granular changes, white spots, friable mucosa, ulcer, and purulent deposits during fibrogastroduodenoscopy (FGDS)[ط UGI involvement may be unnoticed by the attending physician due to the lack of the knowledge of gastroduodenal lesions, which should raise concerns during UC treatment. Furthermore, there is no established standard or criteria available for patients with UC who should undergo FGDS , because the clinical backgrounds of these patients with UC-associated UGI lesions have not been fully and exactly demonstrated. Specific management may be required for patients with UC-associated UGI lesions. Henceforth, we conducted this study with the aim of describing various UGI tract presentations in UC and their differential diagnosis
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A cross sectionaql study will be conducted in Assuit University hospital .Adult patients diagnosed as UC by clinical date , laboratory ,colonscopy and histopathological examination will undergo : full medical history taking : age, gender, time since the ulcerative colitis diagnosis, History of surgery for ulcerative colitis, medications , history of any upper GIT symptoms nausea , vomiting , epigastric pain , heart burn , dysphagia and hematemsis or melena . complete physical examination , with focus on pulse, blood pressure, body temperature and signs of extra intestinal involvement. Esophagogastro-duodenoscopy Histopathological examination of biopsies taken from any lesions
Key inclusion criteria (3 listed)
- Patients' age is 18 years or above.
- Patient who are diagnosed with UC..
- Patient who are fit to undergo upper endoscopy .
Key exclusion criteria (3 listed)
- Pediatric patients.
- patient refuse to participate at this study
- patient with known upper GIT disorder .
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 |
|---|---|---|
| Upper endoscopyEvaluation of upper gastrointestinal tract lesions in ulcerative colitis patients | Device | – |
Primary outcome
Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients
Time frame: Baseline
The relationship between ulcerative colitis patients and upper gastrointestinal tract lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 34168401Sun Y, Zhang Z, Zheng CQ, Sang LX. Mucosal lesions of the upper gastrointestinal tract in patients with ulcerative colitis: A review. World J Gastroenterol. 2021 Jun 14;27(22):2963-2978. doi: 10.3748/wjg.v27.i22.2963.
- Background: PubMed 29674758Kato R, Iwamuro M, Hiraoka S, Takashima S, Inokuchi T, Takahara M, Kondo Y, Tanaka T, Okada H. Evaluation of the Upper Gastrointestinal Tract in Ulcerative Colitis Patients. Acta Med Okayama. 2018 Apr;72(2):105-113. doi: 10.18926/AMO/55850.
- Background: PubMed 28991840Queliza K, Ihekweazu FD, Schady D, Jensen C, Kellermayer R. Granulomatous Upper Gastrointestinal Inflammation in Pediatric Ulcerative Colitis. J Pediatr Gastroenterol Nutr. 2018 Apr;66(4):620-623. doi: 10.1097/MPG.0000000000001771.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Disorder, 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 3 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 8 Nov 2023. 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?
Contact Gamal A Gaber, Master (01126526545 ext. 1, gmalabnaser96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients (time frame: Baseline). 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 NCT06092593, which also lists 3 linked publications.
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 8 Nov 2023.