NCT01661686

Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-up

Conditions

• Esophageal Cancer
• Esophageal Stenosis

Interventions

Type	Name	Description
DEVICE	Partially covered SEMS	Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
DEVICE	Fully covered SEMS	Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-04-01
• Completion: 2016-10-01
• First posted: 2012-08-09
• Last updated: 2019-10-03
• Results posted: 2019-10-03

Locations

5 sites across 1 country: Netherlands