Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection
NCT ID: NCT01873573
Last Updated: 2017-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2013-07-18
2017-10-16
Brief Summary
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Detailed Description
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Typically, triamcinolone (steroid) injection is given as a standard of care after several esophageal dilations are performed and failed to improve the condition. Therefore, researchers want to find out if adding triamcinolone (steroid) injection at the participant's initial EGD procedure will improve the opening of their esophagus and decrease the need for repeat dilations.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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EGD with Dilation
Standard 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.
Dilation
Dilation 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.
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.
EGD with Dilation, plus Triamcinolone
Standard of Care: EGD with dilation and Triamcinolone injection.
Dilation
Dilation 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.
Triamcinolone Injection
Triamcinolone 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.
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.
Interventions
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Dilation
Dilation 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.
Triamcinolone Injection
Triamcinolone 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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Jason Klapman, M.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Other Identifiers
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MCC-17316
Identifier Type: -
Identifier Source: org_study_id