Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/26/2017 |
Start Date: | July 18, 2013 |
End Date: | October 16, 2017 |
Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures
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.
the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the opening
of their esophagus and decrease the need for repeat dilations.
This is a randomized two-arms cross-over trial. In this study there are two groups, the
control group and the triamcinolone treatment group. The cross-over design will apply only in
the control group when patients are not responding to EGD dilations alone (defined as no
sustained improvement in baseline dysphagia) and they will be allowed to cross-over to the
triamcinolone group and undergo 3 successive EGDs with triamcinolone injection.
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.
control group and the triamcinolone treatment group. The cross-over design will apply only in
the control group when patients are not responding to EGD dilations alone (defined as no
sustained improvement in baseline dysphagia) and they will be allowed to cross-over to the
triamcinolone group and undergo 3 successive EGDs with triamcinolone injection.
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.
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
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Jason Klapman, M.D.
Phone: 813-745-6704
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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