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
Conditions
Interventions
Injection of placebo (saline 0.9%) vs injection of Kenacort (80mg) followed by Savaray dilation up to 16 mm.
Sponsors
Maag-, darm-, leverziekten UMC Utrecht
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Previous dilation; 2. Dysphagia due to (suspicion of) malignant tumour recurrence; 3. Patients unfit for upper endoscopy; 4. Active anastomotic leakage or infection; 5. Recent vaccination with '®alive' vaccine; 6. During the acute phase of viral, bacterial or fungal infections; 7. Known gastric or duodenal ulcera; 8. Previous allergic reaction to one of the substances of Kenacort; 9. A known infection with tropical worms (such as Strongyloide) or parasites; 10. Outpatient visit within 6 months at the treating endosocpist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients dysphagia free after 1 dilation in a period of 6 months (success rate). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Median number of dilation sessions after 6 months follow-up; 2. Time to repeat dilation; 3. Number of adverse events and serious adverse events; 4. Dysphagia will be evaluated using a validated questionnaire, the Mayo dysphagia Questionnaire (MDQ)41; 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; 6. Patient's satisfaction with the administered therapy (scored by a visual analogue scale). | — |
Contacts
Public ContactM.M.C. Hirdes
P.O. Box 85500, 3508 GA Utrecht
Outcome results
None listed