Clinical Trial: Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures

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 Summary:

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.


Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Final Dysphagia Score [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: June 4, 2013
Date Started: July 18, 2013
Date Completion: December 2017
Last Updated: April 26, 2017
Last Verified: February 2017