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

NCT ID: NCT07057986

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-08-01

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.

Conditions

Eosinophilic Esophagitis (EoE)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with suspected or confirmed diagnosis of Eosinophilic esophagitis

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

Group Type: EXPERIMENTAL

Trans cervical or abdominal ultrasound

Intervention Type: DEVICE

ultrasound assessment before the scheduled upper endoscopy.

Interventions

Trans cervical or abdominal ultrasound

ultrasound assessment before the scheduled upper endoscopy.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Asaf Levartovsky, MD

Role: CONTACT

asaflevartovsky.research@sheba.health.gov.il

97235307072 ext. 7072

Revital Dvir

Role: CONTACT

revital.dvir@sheba.health.gov.il

97235307072 ext. 7072

Other Identifiers

SHEBA-25-2153-AL-CTIL

Identifier Type: -

Identifier Source: org_study_id