ocal Glucocorticoid Injektion in the Treatment of Benign Oesophageal Strictures, a Randomized Clinical Study

Conditions: Patients with benign oesophageal strictures and symptoms where dilatation of the stricture is planned.
MedDRA version: 8.1Level: LLTClassification code 10030199Term: Oesophageal stricture

Registration Number: EUCTR2006-005856-33-SE

Lead Sponsor: The Department of Molecular Medicin and Surgery, P9:03, Karolinska Institutet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

Informed consent from patient with symtoms due to benign oesophageal stricture where dilatation of the stricture is planned.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients unable to informed consent.
Pregnant or nursing women.
Patients with infectious disease or septicemia.
Patients with known allergy against methylprednisolone.
Patients under 18 years of age.
Malignant stricture.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary objective are median number of days to restricture with the need for dilatation.;Primary end point(s): The return of dysphagia within six weeks. <br> ;Main Objective: Common cause for beingn oesophagel strictures are the postoperative anastomosis, gastrooesophageal reflux disease and after ingestion of corrosive materials. Restricture rate after dilatation of benign oesophageal strictures are high. <br><br>The main objective is to study the effect on stricture diameter before and 6 weeks after dilatation, when intralesional injection of methylprednisolone (compared to placebo) is added to dilatation of benign oesophageal strictures.

Secondary Outcome Measures