Comparisonof the use of Mitomycin C and Triamcinolone in the management of esophageal strictures inchildren which are refractory to standard management
- Conditions
- Health Condition 1: K23- Disorders of esophagus in diseasesclassified elsewhere
- Registration Number
- CTRI/2019/01/017262
- Lead Sponsor
- Rishi Bolia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
All children ( < 13 years ) with refractory or recurrent esophageal strictures , irrespective of the etiology will be included for the trial.
- 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 < 5 years) over
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of Triamcinolone vs. Mitomycin â?? C application vs. standard <br/ ><br>management in terms of <br/ ><br>1. Number of sessions of dilatations needed to achieve the target esophageal lumen <br/ ><br>diameter <br/ ><br>2. Number of sessions of dilatations needed for alleviation of dysphagia <br/ ><br>3. Number of patients having a recurrence of symptomsTimepoint: Both triamcinolone or Mitomycin C will be used for a maximum of 4 consecutive sessions. <br/ ><br>After each dilation, patients will remain under observation for at least 4 h. A repeat session <br/ ><br>of dilatation will be performed after 2-3 weeks.
- Secondary Outcome Measures
Name Time Method noneTimepoint: N/A