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

Sheba Medical Center

Status: Not yet enrolling

Conditions: Eosinophilic Esophagitis (EoE)

Treatments: Device: Trans cervical or abdominal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07057986

SHEBA-25-2153-AL-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Patients with suspected or confirmed diagnosis of Eosinophilic esophagitis

Experimental group

Description:

Patients will undergo trans-cervical or abdominal ultrasound before their scheduled upper endoscopy with biopsies.

Treatment:

Device: Trans cervical or abdominal ultrasound