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Completed

NCT Number: NCT01873573

Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Dilatation, Pathologic Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: steroid, corticosteroid, Kenalog 10

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.

Other names: flexible endoscope

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 10, 2013
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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