FindTrial
Sign In

A multicenter double blind placebo-controlled randomised trial for benign esophageal anastomotic strictures: Savary dilation vs savary dilation with Triamcinolon - BASTA-study

A multicenter double blind placebo-controlled randomised trial for benign esophageal anastomotic strictures: Savary dilation vs savary dilation with Triamcinolon - BASTA-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-013259-31-NL
Enrollment
Unknown
Registered
2009-09-10
Start date
2009-12-29
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 first time dysphagia (grade 2-4) due to a benign anastomotic esophageal stricture MedDRA version: 9.1 Level: LLT Classification code 10015449 Term: Esophageal stricture MedDRA version: 9.1 Level: LLT Classification code 10030199 Term: Oesophageal stricture

Interventions

Trade Name: Kenacort-A 40 Product Name: Kenacort A-40 Pharmaceutical Form: Solution for injection CAS Number: 76-25-5 Other descriptive name: TRIAMCINOLONE ACETONIDE Concentration unit: mg/ml milligra

Sponsors

UMC Utrecht
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Anastomotic stricture after esophagectomy with gastroc tube and cervical anastomosis - Patients with dysphagia grade 2-4 (unable to swallow solid or semisolid food, or unable to swallow liquids or unable to swallow anything) 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: - Previous dilatation - Dysphagia due to (suspicion of) malignant tumour recurrence - Patients unfit for upper endoscopy - Anastomotic leakage or infection - Recent vaccination with ‘alive’ vaccine - During the acute phase of viral, bacterial or fungal infections - Known gastric or duodenal ulcera - Previous allergic reaction to one of the substances of Kenacort - A known infection with tropical worms (such as Strongyloide) or parasites

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the effect of intralesional steroids on the median time to repeat dilation and the rate of patients dysphagia free after 6 months follow-up witin 3 or less dilation sessions;Secondary Objective: To evaluate safety, quality of life and patients' satisfaction after treatment with or without steroids ;Primary end point(s): - Time to repeat dilatation - Number of patients dilatation free after 3 dilatation sessions after 6 months follow-up (success rate)—

Countries

Netherlands

Outcome results

None listed

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