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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07057986
Enrollment
100
Registered
2025-07-10
Start date
2025-08-01
Completion date
2028-08-01
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis (EoE)

Keywords

eosinophilic esophagitis

Brief summary

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

DEVICETrans cervical or abdominal ultrasound

ultrasound assessment before the scheduled upper endoscopy.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between US-measured esophageal thickness and Eosinophilic Esophagitis Endoscopic Reference Score / histological eosinophil counts.6 monthsComparison 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.

Contacts

Primary ContactAsaf Levartovsky, MD
asaflevartovsky.research@sheba.health.gov.il97235307072
Backup ContactRevital Dvir
revital.dvir@sheba.health.gov.il97235307072

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026