Trans-Cervical and Trans-abdominal Ultrasound for Monitoring Esophageal Thickness in Eosinophilic Esophagitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trans cervical or abdominal ultrasound.
- Who it may be relevant to
- Registry conditions: Eosinophilic Esophagitis (EoE). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease characterized by eosinophilic infiltration of the esophageal mucosa, leading to symptoms of dysphagia and food impaction. Currently, upper endoscopy with biopsy is the gold standard for diagnosis and disease monitoring, but it is invasive, costly, and associated with procedural risks. The investigators want to use ultrasound imaging as a non-invasive assessment of esophageal wall thickness as a surrogate marker for mucosal inflammation. Participants will undergo ultrasound assessment at the same day of endoscopy, and than after 3-6 months (optional). The correlation between US-measured esophageal thickness and histological eosinophil counts will be measured.
Detailed description
Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease characterized by eosinophilic infiltration of the esophageal mucosa, leading to symptoms of dysphagia and food impaction. Currently, upper endoscopy with biopsy is the gold standard for diagnosis and disease monitoring, but it is invasive, costly, and associated with procedural risks.
Recent advances in ultrasound (US) imaging suggest the potential for non-invasive assessment of esophageal wall thickness as a surrogate marker for mucosal inflammation. This study aims to evaluate the efficacy and accuracy of trans-cervical/abdominal ultrasound in assessing esophageal thickness compared to the conventional endoscopic evaluation in patients with suspected or confirmed EoE. If validated, this approach could significantly reduce patient burden and reliance on frequent invasive procedures.
Interventions
- Device Trans cervical or abdominal ultrasound
ultrasound assessment before the scheduled upper endoscopy.
Primary outcome measures
- Correlation between US-measured esophageal thickness and Eosinophilic Esophagitis Endoscopic Reference Score / histological eosinophil counts. [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years.
- Suspected or confirmed diagnosis of EoE based on clinical symptoms (e.g., dysphagia, food impaction).
- Scheduled for upper endoscopy with biopsies.
- Able and willing to consent to participation.
Exclusion criteria
- Prior esophageal surgery or anatomical abnormalities.
- Presence of other gastrointestinal disorders affecting the esophagus (e.g., esophageal cancer, achalasia, Barrett's esophagus).
- Pregnancy.
- Inability to undergo US due to anatomical or physical limitations.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07057986 · SHEBA-25-2153-AL-CTIL