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Intralesional Mitomycin-C (MMC) injection has recently been introduced to resolve refractory benign esophageal stricture mostly in children. The investigators aimed to evaluate the clinical efficacy of endoscopic postdilation intralesional injection of MMC in adults with refractory benign esophageal stricture.
The participnts who have refractory benign esophageal stricture even after five or more sessions of bougination are prospectively enrolled. A submucosal needle injection of 4mL of a MMC preparation (0.5mg/mL) is endoscopically done with a 0.5mL of eight each injection mainly into the tearing esophageal wall, after esophageal bougie dilation is done upto 14mm in diameter. And then, repeated bouginations combined with MMC injection are done with the interval of eight weeks upto 3 times, if dysphagia symptoms recurr with dysphagis score 3 or more. Initial and overall clinical success rates are evaluated with drug and procedure-related complication rates during the follow-up period of at least 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mitomycin C injection group | Experimental | A submucosal needle injection of 4mL of a MMC preparation (0.5mg/mL) into the tearing esophageal wall after esophageal bougie dilation on refractory benign esophageal stricture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial clinical success of mitomycin C injection therapy | the improvement of dysphagia score more than one point after a single mitomycin C injection therapy during overall follow up period | 12 months after mitomycin C injection |
| Overall clinical success of mitomycin C injection therapy | The improvement of dysphagia score more than one point after once or even after over twice mitomycin C injection therapy during follow up period | 12 months after mitomycin C injection |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success of mitomycin C injection therapy | The successful performance of endoscopic mitomycin C injection into the submucosal layer at eight points of dilated stricture circumference after endoscopic dilation therapy | through study completion, an average of 1 year |
| complications |
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Inclusion Criteria:
Exclusion Criteria: Patients who have at least one of following conditions were excluded from our study
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| Name | Affiliation | Role |
|---|---|---|
| Jin Hong Kim | Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | 443-721 | South Korea |
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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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Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
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endoscopic procedure-related adverse events |
| through study completion, an average of 1 year |