Topical Mitomycin C application in management of localized caustic esophageal stricture in children: A double-blinded randomized placebo-controlled trial
Topical Mitomycin C application in management of localized caustic esophageal stricture in pediatric age group: A double-blinded randomized placebo-controlled trial to assess number of dilatation needed by each group to achieve complete resolution of dysphagia
Ain Shams University
40 participants
Jan 1, 2008
Interventional
Conditions
Summary
this trial aims to prove the effect of local Mitomycin C application on caustic esophageal stricture as adjuvent therapy to endoscopic dilatation to prevent refibrosis and decrease incidence of stricture recurrence
Eligibility
Inclusion Criteria1
- All children with localized caustic esophageal stricture (< 3 cm in length as measured radiologically and confirmed by endoscopy
Exclusion Criteria5
- long (> 3 cm) or multiple strictures
- patients underwent previous esophageal surgery
- corrosive induced esophageal perforation
- undilatable stricture
- patients known to have a hypersensitivity or contraindication for MMC
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Interventions
this trial aim to study the effect of topical Mitomycin C application on esophageal stricture site after dilating it endoscopically, aiming to decrease incidence of reccurrence and refibrosis. Mitomycin C dose is prepared to use a concentration of 0.4 mg/ml then piece of gauze soaked with this solution is applied on stricture site for 5 minutes. standard protocol is to do dilatation session every 2 weeks for 3 months then session every month for next 3 months each session of dilatation take about 10 minutes in the first session, dilation is done and assessment of stricture length is done in the second dilation session, dilatation followed by Mitomycin/placebo application is done "application take 5 minutes" in the following sessions, dilatation only is done
Locations(1)
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ACTRN12612000683831