Dysphagia | Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection
Dysphagia research study
What is the primary objective of this study?
The purpose of this pilot study is to find out if adding triamcinolone (steroid) injection at the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the opening of their esophagus and decrease the need for repeat dilations.
Who is eligible to participate?
Inclusion Criteria: - Patients who present for EGD with dilation for dysphagia symptoms thought secondary to either radiation-induced stricture or anastomotic stricture based on history Exclusion Criteria: - Inability to consent for the procedure - Known coagulopathy [International Normalized Ratio (INR) >1.5, Platelets <75 K] - Endoscopic finding of a stricture that is not caused by either radiation or anastomotic narrowing - Nasopharyngeal strictures
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:DilationDilation will be performed by either dilation balloons or over the wire polyvinyl dilators based upon the physician's discretion. Fluoroscopy may be used to aid in endoscopic dilation at the physician's discretion.
Other:Triamcinolone InjectionTriamcinolone is a generic name of a long-acting synthetic corticosteroid and approved for sale in the United States by the U.S. Food and Drug Administration (FDA). After endoscopic dilation is performed, a total of 40-80 mg (physician preference) of triamcinolone (40 mg/ml) will be injected throughout the stricture under direct visualization.
Procedure:Esophagogastroduodenoscopy (EGD)EGD is a test to examine the lining of the esophagus (the tube that connects your throat to your stomach), stomach, and first part of the small intestine. It is done with a small camera (flexible endoscope) that is inserted down the throat.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
EGD with DilationStandard of Care: Esophagogastroduodenoscopy (EGD) with dilation alone. If participants are assigned to Arm A and are not showing any clinical improvements as determined by their physician after the first three endoscopic dilation sessions, then they will be crossed over into Arm B.
EGD with Dilation, plus TriamcinoloneStandard of Care: EGD with dilation and Triamcinolone injection.
Start Date: July 18, 2013
Completed Date: October 16, 2017
Primary Outcome: Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period
Secondary Outcome: Final Dysphagia Score
Study sponsors, principal investigator, and references
Principal Investigator: Jason Klapman, M.D.
Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute