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Study was not approved for Fox Chase Cancer Center's Research Review Committee (RRC)
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This study evaluates Mitomycin C as treatment for dysphagia in adult subjects with documented complex esophageal anastomotic strictures. Patients will be randomized in a double-blinded fashion to topical application of normal saline (NS) or Mitomycin C (MMC) at the time of time of index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin C | Experimental | Cotton swab or strip of 2x2 cotton gauze soaked with 0.4mg/mL Mitomycin C |
|
| Control | Placebo Comparator | Cotton swab or strip of 2x2 cotton gauze soaked with Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin C | Drug | Topical application of Mytomycin C (MMC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of dysphagia ≥ grade 1 after the dilation procedure | Prevalence of dysphagia grade ≥1 in MMC Vs normal saline treated patients until 6 months after the first follow-up. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of procedures needed to reach dilation goal | calculated from the first treatment procedure until the last one and will be compared between the experimental and the control arm. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
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| ID | Term |
|---|---|
| D004940 | Esophageal Stenosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| Control | Other | Topical application of Normal Saline |
|
|
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |