EndoFLIP Use in Upper GI Tract Stenosis

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.

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