EndoFLIP Use in Upper GI Tract Stenosis

University of Pennsylvania

Status: Terminated

Conditions: Esophageal Stricture; Zenkers Diverticulum; Eosinophilic Esophagitis; Schatzki Ring

Treatments: Device: EndoFLIP

Study type: Observational

Funder types: Other

Identifiers

NCT02354716

819014

Details and patient eligibility

About

The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation.

Full description

To date there is no effective way to objectively characterize and predict response to endoscopic dilation of luminal strictures of the GI tract. Endoscopic dilation allows effective remediation of benign esophageal and upper GI tract strictures. Stricture dilation is performed after the stricture diameter is crudely gauged by the endoscopist. Stricture characteristics are based on the severity of symptoms and appearance. A stricture may be graded as mild, moderate, severe and as to whether or not the endoscope is able to traverse the luminal narrowing. By precisely measuring the diameter and length of a stricture, the endoscopist can know exactly what type of dilation is necessary. Benign esophageal strictures may also be refractory to dilation and thus require multiple sessions, prior to achieving successful remediation. The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation. The study will include patients with strictures referred for endoscopic dilation for the following indications: radiation induced strictures, peptic strictures, RFA induced strictures, EMR induced strictures, eosinophilic esophagitis, Zenkers diverticulum, and strictures related to surgical anastomoses. In patients with benign refractory esophageal strictures referred for endoluminal prostheses EndoFLIP will be used to characterize the stricture prior to stent placement.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > or = to 18 years of age
• Referred for evaluation and treatment of benign esophageal luminal narrowing
• Clinical diagnosis of benign esophageal luminal narrowing with documentation and imaging
• Adult patients with benign refractory esophageal strictures referred for placement of an esophageal stent are eligible for this study
• Willing and able to give informed consent
• No condition or comorbidity which would prevent the patient from undergoing a successful upper endoscopy

Exclusion criteria

• < 18 years of age
• Pregnancy
• History of prior endoscopic dilation* (*unless referred for placement of stent)
• Coagulopathy
• Inability to traverse the stricture using standard techniques
• Patients unable to provide consent

Trial design

5 participants in 1 patient group

EndoFLIP Measurements

Description:

To define the role of a functional luminal imaging probe (EndoFLIP) in benign upper GI luminal narrowing. EndoFlip measurement of the cross sectional area of the narrowing will be obtained prior to and after endoscopic dilation. Patients will follow up for repeat endoscopy and dilation if indicated. EndoFLIP measurements will be made again before and after dilation. The use of EndoFlip may offer insight in to the clinical and endoscopic predictors of successful stricture dilation.

Treatment:

Device: EndoFLIP