Steroid injection in esophageal radiation strictures

• Conditions: Radiation induced esophageal strictures; MedDRA version: 14.1Level: LLTClassification code 10048900Term: Radiation esophagitisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.1Level: LLTClassification code 10030195Term: Oesophageal stenosis acquiredSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2012-001502-26-PT
• Lead Sponsor: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-14
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified