Health Condition 1: K23- Disorders of esophagus in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: Mitomycin C: Cotton pledgets soaked in a solution (0.5 mg/mL) of mytomycin-C will be applied endoscopically directly onto the mucosa post dilation. Two pledgets will be applied for 30 s
Sponsors
Rishi Bolia
Eligibility
Inclusion criteria
Inclusion criteria: All children ( - Refractory strictures will be defined as those in which it is not possible to relieve the anatomic restriction successfully up to a diameter of 14 mm (12.8 mm. in five sessions at 2-3 weekly intervals, due to cicatricial luminal compromise or fibrosis; - Recurrent strictures will be defined as those in which it is not possible to maintain a satisfactory luminal diameter for 4 wk once the target diameter of 14 mm (12.8 mm < 5 years ) has been achieved
Exclusion criteria
Exclusion criteria: - All patients who have received Mitomycin C or triamcinolone in the past. - Achalasia cardia - Patients with a history of iatrogenic perforation while undergoing dilataion - Patients / guardian refusal to give consent / assent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Triamcinolone vs. Mitomycin â?? C application vs. standard management in terms of 1. Number of sessions of dilatations needed to achieve the target esophageal lumen diameter 2. Number of sessions of dilatations needed for alleviation of dysphagia 3. Number of patients having a recurrence of symptomsTimepoint: Both triamcinolone or Mitomycin C will be used for a maximum of 4 consecutive sessions. After each dilation, patients will remain under observation for at least 4 h. A repeat session of dilatation will be performed after 2-3 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| noneTimepoint: N/A | — |
Countries
India
Contacts
Public ContactRishi Kumar Bolia
Postgraduate Institute of Medical Education and Research (PGIMER)
Outcome results
None listed