Photoacoustic Endoscopy of Barrett's Esophagus

Early Phase 1

Completed

• Conditions: Barrett Esophagus
• Interventions: Procedure: Photoacoustic endoscopy; Procedure: Endoscopic ultrasound (standard of care); Procedure: Endoscopic surgery (standard of care)

• Registration Number: NCT02606292
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. However, this technique only images the surface and cannot effectively diagnose diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases. This technique can image very deep areas of organs, up to several centimeters; however, it suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue abnormalities that do not show mechanical properties that differ significantly from those of normal tissues.

The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned need.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-17
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Aged 18 years and older.
• Patients with Barrett's esophagus scheduled for esophageal surgery.
• Patients with GERD, but without Barrett's esophagus, scheduled for esophageal surgery.
• Subjects must be able to understand and willing to sign a written informed consent form.

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Exclusion Criteria

• Inability to give informed consent.
• Pregnancy.
• Age less than 18 years
• Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection).
• Acute GI bleeding.
• Coagulopathy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: PAE assessment	Endoscopic ultrasound (standard of care)	-The PAE-EUS assessment will be performed in the operating room by the after induction of general anesthesia and following strict sterile technique while the patient is being positioned and prepped for esophageal surgery.
Arm 1: PAE assessment	Endoscopic surgery (standard of care)	-The PAE-EUS assessment will be performed in the operating room by the after induction of general anesthesia and following strict sterile technique while the patient is being positioned and prepped for esophageal surgery.
Arm 1: PAE assessment	Photoacoustic endoscopy	-The PAE-EUS assessment will be performed in the operating room by the after induction of general anesthesia and following strict sterile technique while the patient is being positioned and prepped for esophageal surgery.

Primary Outcome Measures

Name	Time	Method
Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium	Day 1	-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
Sensitivity and specificity of PA endoscopic imaging for identification of Barrett's epithelium compared to esophageal biopsy	Day 1	-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States