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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000683831

Enrollment

Registered

2012-06-26

Start date

2008-01-01

Completion date

Unknown

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

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

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

1 Years to 14 Years

Healthy volunteers

Inclusion criteria

All children with localized caustic esophageal stricture (< 3 cm in length as measured radiologically and confirmed by endoscopy

Exclusion criteria

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

Outcome results