Dysphagia Clinical Trial
Official title:
Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures
Verified date | October 2017 |
Source | H. Lee Moffitt Cancer Center and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 16, 2017 |
Est. primary completion date | August 25, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Final Dysphagia Score | 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. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03711474 -
Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)
|
Phase 4 | |
Enrolling by invitation |
NCT04074356 -
Non-invasive Markers of Esophageal Function in Adults
|
N/A | |
Suspended |
NCT04349462 -
Post Critical Illness Dysphagia in the Intensive Care Unit
|
N/A | |
Not yet recruiting |
NCT05982977 -
Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
|
N/A | |
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Active, not recruiting |
NCT03455608 -
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
|
N/A | |
Active, not recruiting |
NCT03604822 -
Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS
|
N/A | |
Recruiting |
NCT03682081 -
Interventions for Patients With Alzheimer's Disease and Dysphagia
|
N/A | |
Completed |
NCT05700838 -
Refining Cough Skill Training in Parkinson's Disease and Dysphagia
|
Phase 1 | |
Not yet recruiting |
NCT04064333 -
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
|
N/A | |
Not yet recruiting |
NCT02724761 -
Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion
|
N/A | |
Completed |
NCT02927691 -
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
|
Phase 2 | |
Completed |
NCT01919112 -
Fostering Eating After Stroke With Transcranial Direct Current Stimulation
|
N/A | |
Completed |
NCT01370083 -
Tongue Pressure Profile Training for Dysphagia Post Stroke
|
Phase 2 | |
Completed |
NCT01723358 -
Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia
|
Phase 2 | |
Withdrawn |
NCT01200147 -
Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
|
N/A | |
Completed |
NCT00570557 -
Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia
|
N/A | |
Recruiting |
NCT00166751 -
Sonographic Assessment of Laryngeal Elevation
|
N/A | |
Completed |
NCT01476241 -
Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist
|
N/A | |
Completed |
NCT00717028 -
Functional Endoscopic Evaluation of Swallowing
|
N/A |