Esophageal Stricture
Conditions
Keywords
Esophageal Stricture, mitomycin C, endoscopy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEndoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture
Sponsors
Ajou University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
Eligibility
Sex/Gender
ALL
Age
29 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* aged more than 29 year and less than 75 year * refractory benign esophageal stricture who had the symptoms of dysphagia score suggested by Mellow et al greater than 3 (0: able to eat a normal diet, 1: able to eat some solid food, 2: able to eat some semi-solids only, 3: able to swallow liquids only, 4: complete dysphagia)
Exclusion criteria
Patients who have at least one of following conditions were excluded from our study * malignant esophageal stricture * multiple sites of esophageal stricture * pregnant or breast feeding status * clinical deterioration not tolerated to endoscopic procedures * esophageal motility disorders * esophageal leakage or fistula * hypersensitivity to mitomycin C * bleeding tendency due to thrombocytopenia or clotting disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial clinical success of mitomycin C injection therapy | 12 months after mitomycin C injection | the improvement of dysphagia score more than one point after a single mitomycin C injection therapy during overall follow up period |
| Overall clinical success of mitomycin C injection therapy | 12 months after mitomycin C injection | The improvement of dysphagia score more than one point after once or even after over twice mitomycin C injection therapy during follow up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of mitomycin C injection therapy | through study completion, an average of 1 year | The successful performance of endoscopic mitomycin C injection into the submucosal layer at eight points of dilated stricture circumference after endoscopic dilation therapy |
| complications | through study completion, an average of 1 year | endoscopic procedure-related adverse events |
Countries
South Korea
Outcome results
None listed