Intralesional steroid injection in radiation-induced esophageal strictures

INTERVENTION: Trade Name: TRIGON DEPOT 40 mg/ml suspensión inyectable Pharmaceutical Form: Suspension for injection CAS Number: 76‐25‐5 Other descriptive name: TRIAMCINOLONE ACETONIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intralesional use CONDITION: Radiation induced esophageal strictures ; MedDRA version: 14.1 Level: LLT Classification code 10048900 Term: Radiation esophagitis System Organ Class: 10022117 ‐ Injury, poisoning and procedural complications ; MedDRA version: 14.1 Level: LLT Classification code 10030195 Term: Oesophageal stenosis acquired System Organ Class: 10017947 ‐ Gastrointestinal disorders Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Therapeutic techniques [E02] PRIMARY OUTCOME: Main Objective: Compare the number of dilations required to maintain a dysphagia score 0‐1, during a 12 months period in patients trearted with triamcinolone in comparison with placebo.; ; Primary end point(s): Number of dilations required to maintain a dysphagia grade of 0 or 1 (Ogilvie score) Secondary Objective: To evaluate the efficacy of with triamcinolone in comparison with placebo in what regards:; ‐ Compare the dysphagia grade at 2 weeks after the first esophageal dilation; ; ‐ Compare the mean time between first and second dilation, to maintain a dysphagia grade 0‐1; ; ‐ In patients submitted to 3 dilations with injection, compare the mean time between the third and the fourth dilation and the grade of dysphagia 3 weeks after the third dilation; ; ‐ Compare the mean time between dilations, in the period of 12 months, to maintain a dysphagia grade of 0‐1. ; Timepoint(s) of evaluation of this end point: Schedule follow‐up:; • Clinical visits: 3 months and 12 months (end of study).; • Phone call: 1 week, 2 weeks, 1 month, 2 months, 4 months, 6 months, 9 months and SOS if dysphagia / worsening dysphagia SECONDARY OUTCOME: Secondary end point(s): ‐ Dysphagia grade at 2 weeks after the first esophageal dilation (Ogilvie score); ; ‐ Mean time between first and second dilation, to maintain a dysphagia grade 0‐1; ; ‐ In patients submitted to 3 dilations with injection, compare the mean time between the third and the fourth dilation and the grade of dysphagia 3 weeks after the third dilation; ; ‐ Mean time between dilations, in the period of 12 months, to maintain a dysphagia grade of 0‐1. Timepoint(s) of evaluation of this end point: Schedule follow‐up: ; • Clinical visits: 3 months and 12 months (end of study). ; • Phone call: 1 week, 2 weeks, 1 month, 2 months, 4 months, 6 months, 9 months and SOS if dysphagia / worsening dysphagia INCLUSION CRITERIA: 1. Obtaining informed consent; 2. Age >18 years; 3. Radiation‐induced esophageal (or hipopharynx) stricture: ‐ previously dilated to a diameter equal or superior to 12 mm and requiring at least one new dilation session over a period of 12 months or ‐ impossibility of dilation up to 12 mm after two dilatation sessions with 2 weeks apart; 4. Dysphagia grade >1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8