Clinical trial NCT02354716: EndoFLIP Use in Upper GI Tract Stenosis
Official title: Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Esophageal Stricture
Eosinophilic Esophagitis
Zenkers Diverticulum
Schatzki Ring
Keywords: esophagus
upper GI
endoscopy
endoFLIP
functional luminal imaging
esophageal stricture
narrow esophagus
narrow caliber esophagus
esophageal narrowing
eosinophilic esophagitis
Zenkers diverticulum
Schatzki ring
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with benign refractory esophageal strictures referred for placement of an esophageal stent are eligible for this study.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Collection of Measurements of the Luminal Narrowing Using EndoFlip
timeFrame: 12 Months
Secondary outcomes:
measure: Observation of Pre-Endoscopic Therapy EndoFLIP Measurements
timeFrame: 12 Months
measure: Observation of Post-Endoscopic Therapy EndoFLIP Measurements
timeFrame: 12 Months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael L Kochman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Vinay Chandrasekhara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Gregory G Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
References: