Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Dysphagia

Treatments: Procedure: Dilation; Other: Triamcinolone Injection; Procedure: Esophagogastroduodenoscopy (EGD)

Study type: Interventional

Funder types: Other

Identifiers

NCT01873573

MCC-17316

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

EGD with Dilation

Active Comparator group

Description:

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.

Treatment:

Procedure: Dilation

Procedure: Esophagogastroduodenoscopy (EGD)

EGD with Dilation, plus Triamcinolone

Active Comparator group

Description:

Standard of Care: EGD with dilation and Triamcinolone injection.

Treatment:

Procedure: Dilation

Procedure: Esophagogastroduodenoscopy (EGD)

Other: Triamcinolone Injection