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NCT Number: NCT07057986

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trans cervical or abdominal ultrasound

Device

ultrasound assessment before the scheduled upper endoscopy.

Primary outcomes

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

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Asaf Levartovsky, MD

CONTACT

[email protected]

97235307072 ext. 7072

Revital Dvir

CONTACT

[email protected]

97235307072 ext. 7072

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 10, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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