Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| EGD with Dilation, plus Triamcinolone | Active Comparator | Standard of Care: EGD with dilation and Triamcinolone injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason Klapman, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004106 | Dilatation |
| D014221 | Triamcinolone |
| D013256 | Steroids |
| D000305 | Adrenal Cortex Hormones |
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
|
| 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. |
|
|
| D010038 | Otorhinolaryngologic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |