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

NCT07057986 | Not Yet Recruiting

• 1 other identifier: SHEBA-25-2153-AL-CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eosinophilic Esophagitis (EoE)

Keywords

eosinophilic esophagitis

Outcome Measures

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.

  6 months

Study Arms (1)

Patients with suspected or confirmed diagnosis of Eosinophilic esophagitis

EXPERIMENTAL

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

Device: Trans cervical or abdominal ultrasound

Interventions

Trans cervical or abdominal ultrasound DEVICE

ultrasound assessment before the scheduled upper endoscopy.

Patients with suspected or confirmed diagnosis of Eosinophilic esophagitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Asaf Levartovsky, MD

CONTACT

97235307072; asaflevartovsky.research@sheba.health.gov.il

Revital Dvir

CONTACT

97235307072; revital.dvir@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Will be available at study conclusion
• Access Criteria: Access by request to the PI