Status:
COMPLETED
Mitomycin-C Injection Therapy in Refractory Esophageal Stricture
Lead Sponsor:
Ajou University School of Medicine
Conditions:
Esophageal Stricture
Eligibility:
All Genders
29-75 years
Phase:
NA
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 o...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04284826
Start Date
October 1 2013
End Date
August 31 2018
Last Update
February 28 2020
Active Locations (1)
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1
Ajou University Hospital
Suwon, South Korea, 443-721