Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection

NCT01873573 | Completed

• 1 other identifier: MCC-17316
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

radiation-induced stricture; anastomotic stricture; esophagogastroduodenoscopy (EGD); dilation; steroid injection; triamcinolone; difficulty swallowing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Final Dysphagia Score

  12 months

Study Arms (2)

EGD with Dilation

ACTIVE COMPARATOR

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.

Procedure: Dilation; Procedure: Esophagogastroduodenoscopy (EGD)

EGD with Dilation, plus Triamcinolone

ACTIVE COMPARATOR

Standard of Care: EGD with dilation and Triamcinolone injection.

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

Interventions

Dilation PROCEDURE

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.

EGD with Dilation; EGD with Dilation, plus Triamcinolone

Triamcinolone Injection OTHER

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.

Also known as: steroid, corticosteroid, Kenalog 10

EGD with Dilation, plus Triamcinolone

Esophagogastroduodenoscopy (EGD) PROCEDURE

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.

Also known as: flexible endoscope

EGD with Dilation; EGD with Dilation, plus Triamcinolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who present for EGD with dilation for dysphagia symptoms thought secondary to either radiation-induced stricture or anastomotic stricture based on history

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Dilatation, Pathologic

Interventions

Dilatation; Triamcinolone; Steroids; Adrenal Cortex Hormones; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jason Klapman, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 10, 2013
• Study Start: July 18, 2013
• Primary Completion: August 25, 2016
• Study Completion: October 16, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

US (1)