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

Foundation for Liver Research5 sites in 1 country98 target enrollmentJuly 2012

ConditionsEsophageal Cancer Esophageal Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Esophageal Cancer
Sponsor: Foundation for Liver Research
Enrollment: 98
Locations: 5
Primary Endpoint: Number of Participants With Recurrent Dysphagia.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

October 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Foundation for Liver Research

Responsible Party

Principal Investigator

Manon Spaander

M.D., PhD

Foundation for Liver Research

Eligibility Criteria

Inclusion Criteria

•Malignant stricture of the esophagus or cardia
•No curative treatment options available
•Dysphagia grade of at least 2 (i.e. swallow semi-solid foods or less)
•Informed consent
•Age ≥ 18 years

Exclusion Criteria

•Previous treatment with self-expandable metal stent for same condition
•Evidence of tumor within 2 cm of the upper esophageal sphincter.
•Presence of an esophago-tracheal or -bronchial fistula or both.
•Not able to undergo upper endoscopy

Outcomes

Primary Outcomes

Number of Participants With Recurrent Dysphagia.

Time Frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.

This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.

Secondary Outcomes

Number of Participants With Technical Success of SEMS Placement(At stent placement (t=0))
Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score(From stent placement until death or placement of second stent, assessed up to 6 months.)
Number of Participants in Whom a Major Complication Has Occured(From stent placement until death or placement of second stent, assessed up to 6 months)
Median Survival After SEMS Placement(From stent placement until death or placement of second stent)