EndoFLIP Use in Upper GI Tract Stenosis

NCT ID: NCT02354716

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-01-31

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.

Conditions

Esophageal Stricture; Eosinophilic Esophagitis; Zenkers Diverticulum; Schatzki Ring

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

EndoFLIP Measurements

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.

EndoFLIP

Intervention Type: DEVICE

The Endolumenal Functional Lumenal Imaging Probe Imaging System is a technology developed to measure the dimensions \& function of a variety of hollow organs throughout the body. Since receiving FDA clearance for sale in the United States EndoFLIP has been used in a variety of clinical applications. We intend to investigate the potential clinical applications of EndoFLIP in the upper GI tract in patients with esophageal stenoses who require endoscopic therapy for benign esophageal strictures. The use of EndoFLIP to characterize a stricture pre- \& post- dilation may offer insight in to the clinical and endoscopic predictors of successful stricture dilation, \& what characteristics determine \& predict refractory \& recurrent strictures.

Interventions

EndoFLIP

The Endolumenal Functional Lumenal Imaging Probe Imaging System is a technology developed to measure the dimensions \& function of a variety of hollow organs throughout the body. Since receiving FDA clearance for sale in the United States EndoFLIP has been used in a variety of clinical applications. We intend to investigate the potential clinical applications of EndoFLIP in the upper GI tract in patients with esophageal stenoses who require endoscopic therapy for benign esophageal strictures. The use of EndoFLIP to characterize a stricture pre- \& post- dilation may offer insight in to the clinical and endoscopic predictors of successful stricture dilation, \& what characteristics determine \& predict refractory \& recurrent strictures.

Intervention Type: DEVICE

Other Intervention Names

Endolumenal Functional Lumenal Imaging Probe

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael L Kochman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Vinay Chandrasekhara, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Gregory G Ginsberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

819014

Identifier Type: -

Identifier Source: org_study_id