benign esophageal narrowing benign esophageal stricture
Conditions
Interventions
Dilation is carried out with the Savary bougie dilator in both groups. The
stricture will be dilated to a diameter of 16-18mm, according to the preference
of the endoscopist. As a general rule in da
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Dysphagia due benign esophageal stricture requiring esophageal dilation (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy) - Requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter) - No history of esophageal endoscopic dilations for benign strictures the past 6 months - Dysphagia for solid, semisolid or liquid food (dysphagia score
Exclusion criteria
Exclusion criteria: - Patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to prospectively evaluate the efficacy of esophageal dilation according to the rule of 3 compared with the rule of > 3 in patients with severe benign esophageal strictures. Efficacy: - Total number of dilation sessions during dilation to 16-18mm and within 6 months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm (measured with dysphagia diary) - Time from first dilation session to dilation of 16-18mm - Time to dilation of recurrent stricture after initial dilation to 16-18mm - Safety: mortality, serious adverse event and adverse events - Quality of Life (measured with EQ5D questionnaire) - Direct medicals costs: procedures, secondary interventions - Technical success * Definition: defined as ease of dilation with multiple Savary bougie implantations of different sizes at the required location of stenosis. | — |
Countries
Netherlands
Outcome results
None listed