Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection
- Conditions
- Dysphagia
- Interventions
- Procedure: DilationProcedure: Esophagogastroduodenoscopy (EGD)Other: Triamcinolone Injection
- Registration Number
- NCT01873573
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Patients who present for EGD with dilation for dysphagia symptoms thought secondary to either radiation-induced stricture or anastomotic stricture based on history
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description EGD with Dilation 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. EGD with Dilation Esophagogastroduodenoscopy (EGD) 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. EGD with Dilation, plus Triamcinolone Triamcinolone Injection Standard of Care: EGD with dilation and Triamcinolone injection. EGD with Dilation, plus Triamcinolone Dilation Standard of Care: EGD with dilation and Triamcinolone injection. EGD with Dilation, plus Triamcinolone Esophagogastroduodenoscopy (EGD) Standard of Care: EGD with dilation and Triamcinolone injection.
- Primary Outcome Measures
Name Time Method Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period 12 months The main outcome measured will be number of visits to receive Esophageal Dilation during the 12-month follow-up period. Successful dilation of the stricture for the procedure will be defined as creation of a mucosal tear confirmed by endoscopic visualization after the last dilation is performed.
- Secondary Outcome Measures
Name Time Method Final Dysphagia Score 12 months Dysphagia Scoring System: 0 = able to eat normal diet / no dysphagia; 1 = able to swallow some solid foods; 2 = able to swallow only semi solid foods; 3 = able to swallow liquids only; 4 = unable to swallow anything / total dysphagia.
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States