Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:November 1, 2017
End Date:October 31, 2022
Contact:Megan E LaMotte
Email:melamotte@geisinger.edu
Phone:570-214-2411

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Post Procedural Pain Assessment in Patients Undergoing Balloon Cryotherapy Compared to Radiofrequency Ablation (RFA) for Dysplastic Barrett's: A Prospective Study

Barrett's esophagus is a condition in which the normal lining of the lower esophagus is
replaced with cells that predispose an individual to development of esophageal cancer.
Treatment of Barrett's esophagus reduces the risk of progression to cancer. Treatment is
provided endoscopically, via a variety of approved techniques including endoscopic mucosal
resection, argon plasma coagulation, radiofrequency ablation (RFA), spray cryotherapy
ablation and balloon cryotherapy ablation. A common side effect of ablation treatment is
pain, thus making pain an important factor when discussing treatment options. It is
speculated that balloon cryotherapy causes less pain than RFA but no head-to-head comparison
trials exist to date. This multi-center, prospective cohort study aims to compare pre- and
post-procedural pain for balloon cryotherapy versus RFA. Providing both patients and
clinicians with data from a well-designed prospective study may help guide future
physician/patient treatment discussions.


Inclusion Criteria:

1. Patients with dysplastic Barrett's esophagus (LGD and HGD) naïve to ablation therapy
presenting for ablation

2. Age ≥ 18

3. Ability to sign informed consent

Exclusion Criteria:

1. Prior ablation treatment for Barrett's esophagus

2. Pregnancy
We found this trial at
4
sites
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: George Smallfield, MD
Phone: 8046284570
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Phone: 570-214-2411
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Queens, New York 11042
Phone: 718-470-7997
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Queens, NY
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