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CompletedPhase 2Phase 3ACTRN12613001070729

The effect of Mitomycin C in children with long caustic esophageal strictures

The effect of topical Mitomycin C application on resolution of dysphagia in children with long segment caustic esophageal strictures

Sponsor

Pediatric Surgery Department, Ain Shams University

Enrollment

20 participants

Start Date

Jan 16, 2009

Study Type

Interventional

Conditions

dysphagia in children with caustic esophageal stricture

Summary

long caustic esophageal strictures are usually difficult to be managed and have poor response to frequent endoscopic dilatation. Therefore, esophageal replacement is eventually indicated for these children. Topical mitomycin C (MMC) application has been recently used to improve the results of endoscopic dilatation for localized esophageal strictures. Our aim is to assess the role of MMC application in management of long segment caustic esophageal strictures.

Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 6 Yearss

Inclusion Criteria1

  • patients with long segment (> 3 cm) caustic esophageal stricture

Exclusion Criteria4

  • short strictures (< 3 cm in length)
  • patients underwent previous esophageal surgery
  • undilatable strictures
  • patients known to have a hypersensitivity or contraindication for mitomycin c

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Interventions

topical mitomycin c is applied on the site of esophageal stricture after endoscopic dilatation. mitomycin c is prepared to have a concentration of 0.5 mg/ml to be applied on the stricture site for 5

topical mitomycin c is applied on the site of esophageal stricture after endoscopic dilatation. mitomycin c is prepared to have a concentration of 0.5 mg/ml to be applied on the stricture site for 5 minutes. this application is done once for 5 min at the session of endoscopic dilatation session. endoscopic dilatation is done using flexible endoscopy and wire guided malleable dilator, we perform a dilatation session every 2 weeks in first 3 months then monthly for the next 9 months. endoscopic dilatation is done regularly at this scheduled sessions, and mitomycin application is done every other session . this applied for 2 to 6 times according to the response of each patient and the improvement of his dysphagia ( if he get free after 2 application, no more sessions is needed)(and if he didn't get improved , we continue to 6 application times).

Locations(1)

Egypt

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ACTRN12613001070729