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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06092593
Other study ID # Upper endoscopy UC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date October 2025

Study information

Verified date October 2023
Source Assiut University
Contact Gamal A Gaber, Master
Phone 01126526545
Email gmalabnaser96@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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 .


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date October 2025
Est. primary completion date January 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients' age is 18 years or above. - Patient who are diagnosed with UC.. - Patient who are fit to undergo upper endoscopy . Exclusion Criteria: - Pediatric patients. - patient refuse to participate at this study - patient with known upper GIT disorder .

Study Design


Intervention

Device:
Upper endoscopy
Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Kato 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. — View Citation

Queliza 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients The relationship between ulcerative colitis patients and upper gastrointestinal tract lesions Baseline
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