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Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection

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ClinicalTrials.gov Identifier: NCT01873573
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dysphagia Procedure: Dilation Other: Triamcinolone Injection Procedure: Esophagogastroduodenoscopy (EGD) Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures
Actual Study Start Date : July 18, 2013
Actual Primary Completion Date : August 25, 2016
Actual Study Completion Date : October 16, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: EGD with Dilation
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
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.

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.
Other Name: flexible endoscope
Active Comparator: EGD with Dilation, plus Triamcinolone
Standard of Care: EGD with dilation and Triamcinolone injection.
 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.
Other Names:
  • steroid
  • corticosteroid
  • Kenalog 10

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.
Other Name: flexible endoscope


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873573


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Jason Klapman, M.D. H. Lee Moffitt Cancer Center and Research Institute
More Information
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Additional Information:

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01873573    
Other Study ID Numbers: MCC-17316
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
radiation-induced stricture
anastomotic stricture
esophagogastroduodenoscopy (EGD)
dilation
 steroid injection
triamcinolone
difficulty swallowing
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical
Triamcinolone
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs