NCT06092593

Brief 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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 8, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 28, 2023

Last Update Submit

November 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients

    The relationship between ulcerative colitis patients and upper gastrointestinal tract lesions

    Baseline

Interventions

Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients' age is 18 years or above.
  • Patient who are diagnosed with UC..
  • Patient who are fit to undergo upper endoscopy .

You may not qualify if:

  • Pediatric patients.
  • patient refuse to participate at this study
  • patient with known upper GIT disorder .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 34168401BACKGROUND
  • 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.

    PMID: 29674758BACKGROUND
  • 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.

    PMID: 28991840BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Gamal A Gaber, Master

CONTACT

Muhammad Abass el masry, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 23, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

October 1, 2025

Last Updated

November 8, 2023

Record last verified: 2023-10