EndoFLIP Use in Upper GI Tract Stenosis

Terminated

• Conditions: Esophageal Stricture; Eosinophilic Esophagitis; Zenkers Diverticulum; Schatzki Ring
• Interventions: Device: EndoFLIP

• Registration Number: NCT02354716
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EndoFLIP Measurements	EndoFLIP	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.

Primary Outcome Measures

Name	Time	Method
Collection of Measurements of the Luminal Narrowing Using EndoFlip	12 Months	The study is observational and a proof of concept study. Measurements of the luminal narrowing using EndoFLIP will be obtained.

Secondary Outcome Measures

Name	Time	Method
Observation of Pre-Endoscopic Therapy EndoFLIP Measurements	12 Months	Patients will undergo the clinically indicated procedure for benign esophageal luminal narrowing remediation. Before undergoing clinically indicated esophageal therapy, measurements of the luminal narrowing using EndoFLIP will be obtained to identify potential predictors of response to endoscopic therapy. These measurements will included luminal diameter, length of narrowing and narrowing distensibility and will be obtained before and after delivery of the clinically indicated endoscopic therapy.
Observation of Post-Endoscopic Therapy EndoFLIP Measurements	12 Months	After undergoing clinically indicated esophageal therapy at clinically-indicated follow-up endoscopies, measurements of the luminal narrowing using EndoFLIP will again be obtained to identify responses to endoscopic therapy.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States