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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005856-33-SE

Enrollment

Registered

2006-12-22

Start date

2007-02-13

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Depo-Medrol Pharmaceutical Form: Injection* INN or Proposed INN: methylprednisolone Other descriptive name: Depo-Medrol Concentration unit: mg milligram(s) Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. ;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. 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.	—

Measure

Time frame

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. ;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. 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.

—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026