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
Conditions
Interventions
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 mill
Sponsors
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent; 2. Allergy to triamcinolone; 3. Severe disease that prevents deep sedation; 4. Thrombocytopenia (platelets <50000/µL) or coagulation disorders (prothrombin rate <60%); 5. Radiation-induced strictures with an ulcerated component.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. ;Primary end point(s): Number of dilations required to maintain a dysphagia grade of 0 or 1 (Ogilvie score);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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Portugal
Contacts
Public ContactDepartment of Gastroenterology
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Outcome results
None listed