malignant dysphagia maligne dysfagie
Conditions
Interventions
Patients with malignant dysphagia due to an inoperable malignant obstruction of the esophagus or gastric cardia will be randomly assigned to be treated with a FC Wallflex stent (Boston Scientific, Nat
Sponsors
University Medical Center Utrecht
Eligibility
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 <40% -Patients unfit to undergo conscious sedation -Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments
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 Ogilvie) as a result of stent dysfunction after initial improvement of dysphagia to < 2. Stent dysfunction is defined as stent migration, tumor in- or overgrowth or food bolus impaction objectified during upper endoscopy. - Major complications due to stent placement are defined as complications leading to hospitalization, unintended prolongation of hospitalization, death or repeat endoscopic intervention with a possible or definite association with stent placement as determined by the treating physician | — |
Secondary
| Measure | Time frame |
|---|---|
| • Technical success; defined as ease of deployment and placement of the stent at the required location and 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). • Major complications not related to stent placement; defined as complications leading to hospitalization, unintended prolongation of hospitalization, death or repeat endoscopic intervention without a possible or definite association with stent placement as determined by the treating physician. • Minor complications due to stent placement; defined as minor complications with a possible or definite association with stent placement as determined by the treating physician. • Minor complications not related to stent placement; defined as minor complications without a possible or definite association with stent placement as determined by the treating physician. • Quality of life; measured with the EQ5D questionnaire. | — |
Contacts
Public ContactW.F.W. Kappelle
P.O. box 85500 University Medical Center Utrecht Department of Gastroenterology & Hepatology Room F02.618
Outcome results
None listed