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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001070729

Enrollment

Registered

2013-09-25

Start date

2009-01-16

Completion date

2011-06-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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).

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

1 Years to 6 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results