An interventional study of Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture in Esophageal Stricture, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 29 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Treatment
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.
50 studies on the registry are indexed under Esophageal Stenosis; 11 are open to participants now.
This study's enrollment of 16 is below the median of 24 across 41 interventional studies indexed under Esophageal Stenosis.
Browse Esophageal Stenosis studies →Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria: Patients who have at least one of following conditions were excluded from our study
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
Procedure: Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture
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
Time frame: 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
Time frame: 12 months after mitomycin C injection
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
Time frame: through study completion, an average of 1 year
complications
endoscopic procedure-related adverse events
Time frame: through study completion, an average of 1 year
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Ajou University School of Medicine