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Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection

Information source: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dysphagia

Intervention: Dilation (Device); Triamcinolone Injection (Drug); Esophagogastroduodenoscopy (EGD) (Device)

Phase: N/A

Status: Recruiting

Sponsored by: H. Lee Moffitt Cancer Center and Research Institute

Official(s) and/or principal investigator(s):
Jason Klapman, M.D., Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Overall contact:
Jason Klapman, M.D., Phone: 813-745-4035, Email: jason.klapman@moffitt.org

Summary

The purpose of this 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period

Secondary outcome: Final Dysphagia Score

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Jason Klapman, M.D., Phone: 813-745-4035, Email: jason.klapman@moffitt.org

UCLA Medical Center, Los Angeles, California 90095, United States; Not yet recruiting
Muthuasamy Venkataraman, M.D., Phone: 310-267-3636, Email: raman@mednet.ucla.edu
Muthuasamy Venkataraman, M.D., Principal Investigator

California Pacific Medical Center, San Francisco, California 94115, United States; Not yet recruiting
Janak Shah, M.D., Phone: 415-600-1151, Email: shahj@sutterhealth.org
Janak Shah, M.D., Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States; Recruiting
Marjorie Brelsford, Phone: 813-745-6704, Email: marjorie.brelsford@moffitt.org
Jason Klapman, M.D., Principal Investigator
Cynthia Harris, M.D., Sub-Investigator

Northwestern University Medical Center, Chicago, Illinois 60611, United States; Not yet recruiting
Sri Komanduri, M.D., Phone: 312-695-0484, Email: koman1973@gmail.com
Sri Komanduri, M.D., Principal Investigator

Additional Information

Moffitt Cancer Center Clinical Trials website

Starting date: July 2013
Last updated: August 7, 2015

Page last updated: August 23, 2015

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