cancerous passage disorder malignant dysphagia
Conditions
Interventions
FC Wallflex stent or FC Egis stent
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Dysphagia due to an inoperable malignant obstruction of the esophagus or gastric cardia. Dysphagia is defined as: dysphagia score of 2-4, according to Ogilvie. Inoperable disease is defined as local tumor infiltration into surrounding organs, distant metastases or a poor general health due to serious concomitant disease -Written informed consent
Exclusion criteria
Exclusion criteria: -Evidence of tumor growth within 2 cm of the upper esophageal sphincter -Tumor length > 12 cm -Previous stent placement for the same condition -Karnofsky performance scale of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite clinical end point of recurrent dysphagia and major complications due to stent placement: - Recurrent dysphagia is defined as a dysphagia score of >= 2 (according to Ogilvie16) as a result of stent dysfunction after initial improvement of dysphagia to | — |
Secondary
| Measure | Time frame |
|---|---|
| -Technical success; defined as an easy deployment and placement of the stent at the required location, verified by fluoroscopy and/or endoscopy. -Pain score during the first 14-days after stent placement; scored by the patient on a visual analogue scale (VAS). -Unrelated major complications -Minor complications -Quality of life (EQ5D) | — |
Countries
Netherlands
Outcome results
None listed