Wallflex stent versus Egis stent for palliation of malignant dysphagia

Phase 4

Completed

Conditions: cancerous passage disorder
malignant dysphagia
10017990

Registration Number: NL-OMON40496

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 116

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

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Composite clinical end point of recurrent dysphagia and major complications due<br /><br>to stent placement:<br /><br>- Recurrent dysphagia is defined as a dysphagia score of >= 2 (according to<br /><br>Ogilvie16) as a result of stent dysfunction after initial improvement of<br /><br>dysphagia to < 2. Stent dysfunction is defined as stent migration, tumor in- or<br /><br>overgrowth or food bolus impaction objectified during upper endoscopy.<br /><br>- Major complications due to stent placement are defined as complications<br /><br>leading to hospitalization, unintended prolongation of hospitalization, death<br /><br>or repeat endoscopic intervention with a possible or definite association with<br /><br>stent placement as determined by the treating physician. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Technical success; defined as an easy deployment and placement of the stent at<br /><br>the required location, verified by fluoroscopy and/or endoscopy.<br /><br>-Pain score during the first 14-days after stent placement; scored by the<br /><br>patient on a visual analogue scale (VAS).<br /><br>-Unrelated major complications<br /><br>-Minor complications<br /><br>-Quality of life (EQ5D)</p><br>