A multicenter, double blind placebo controlled randomized trial for Benign esophageal Anastomotic Strictures: Savary dilation vs savary dilation with TriAmcinolon.
Recruiting
- Conditions
- Patients with dysphagia after esophagectomy with cervical anastomosis due to a benign anastomotic stricture.Patienten met dysfagie na een buismaagreconstructie na slokdarmresectie met een cervicale anastomose veroorzaakt door een benigne anastomotische strictuur
- Registration Number
- NL-OMON26668
- Lead Sponsor
- Maag-, darm-, leverziekten UMC Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Patients with dysphagia grade 2-4 (Atkinson Dysphagia score) after esophagectomy with gastric tube reconstruction and cervical anastomosis;
2. Signed informed consent.
Exclusion Criteria
1. Previous dilation;
2. Dysphagia due to (suspicion of) malignant tumour recurrence;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients dysphagia free after 1 dilation in a period of 6 months (success rate).
- Secondary Outcome Measures
Name Time Method 1. Median number of dilation sessions after 6 months follow-up;<br /><br>2. Time to repeat dilation;<br /><br>3. Number of adverse events and serious adverse events;<br /><br>4. Dysphagia will be evaluated using a validated questionnaire, the Mayo dysphagia Questionnaire (MDQ)41;<br /><br>5. Quality of life: The effect of the treatment on general quality of life will be evaluated by the short form 36 (SF-35) health survey;<br /><br>6. Patient's satisfaction with the administered therapy (scored by a visual analogue scale).