Trans-Cervical and Trans-abdominal Ultrasound for Monitoring Esophageal Thickness in Eosinophilic Esophagitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheba Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Trans cervical or abdominal ultrasound

    Device

    ultrasound assessment before the scheduled upper endoscopy.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with suspected or confirmed diagnosis of Eosinophilic esophagitisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between US-measured esophageal thickness and Eosinophilic Esophagitis Endoscopic Reference Score / histological eosinophil counts.

Comparison of ultrasound results and histological results of eosinophils. Esophagitis Endoscopic Reference score scale: Fixed rings: 0-3, Exudates: 0-2, Furrows: 0-2, Oedema: 0-2, Stricture: 0-1, Feline esophagus: 0-1, Narrow calibre esophagus: 0-1, Crepe paper esophagus: 0-1. Higher scores mean a worse outcome.

Time frame
6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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