Esophageal cancer malignant dysphagia
Conditions
Interventions
Placement of esophageal multisegmented fully covered SEMS
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients; - Requiring treatment for dysphagia (Ogilvie score of 2-4); - Life expectancy of less than 12 months; - Written informed consent; - Age >= 18 years.
Exclusion criteria
Exclusion criteria: - Stenosis after laryngectomy; - Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter; - Tumor length of more than 14 cm; - Esophageal fistula; - Previous stent placement for the same condition; - Inappropriate cultural level and understanding of the study; - Coagulopathy; - Patients with eosinophilic esophagitis or a esohpageal motility disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety: Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain, gastroesophageal reflux and stent migration. Because of the new stent design that should decrease stent migration, we will specifically pay attention to stent migration rates. - Efficacy: Consisting of • Clinical outcome, measured at baseline and during follow-up until death with the Ogilvie dysphagia score; • Technical successful placement of the esophageal multisegmented fully covered SEMS including correct positioning at the stenosis. Technical success is defined as ease of deployment and placement of the stent at the required location. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recurrent dysphagia: cause of dysphagia will be registered during follow-up; - Functional outcome after stent placement: expressed as WHO performance, measured at baseline and during follow-up until death; - Pain related to esophageal stent during follow-up: the first two weeks pain will be measured daily with a patient diary, using the Visual Analogue Scale (VAS). After this, every 4 weeks until death the patient will be contacted with a telephone interview; | — |
Countries
Netherlands
Outcome results
None listed