Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873573
• Other study ID #: MCC-17316
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: October 20, 2017
• Start date: July 18, 2013
• Est. completion date: October 16, 2017

Study information

• Verified date: October 2017
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 16, 2017
• Est. primary completion date: August 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysphagia

Intervention

Procedure:
• 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.

Other:
• 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.

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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period	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.	12 months
Secondary	Final Dysphagia Score	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.	12 months

External Links

•   Moffitt Cancer Center Clinical Trials website