Overview

This trial is active, not recruiting.

Conditions esophageal cancer, esophageal stenosis
Treatments partially covered sems, fully covered sems
Sponsor Foundation for Liver Research
Start date July 2012
End date April 2016
Trial size 98 participants
Trial identifier NCT01661686, COPAC

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
partially covered sems WallFlex Partially covered esophageal stent
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
(Active Comparator)
fully covered sems WallFlex Fully covered esophageal stent
Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Primary Outcomes

Measure
Recurrent dysphagia.
time frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.

Secondary Outcomes

Measure
Technical success of SEMS placement
time frame: At stent placement (t=0)
Clinical success defined as improvement of dysphagia score
time frame: From stent placement until death or placement of second stent, assessed up to 6 months.
Major and minor complication rate
time frame: From stent placement until death or placement of second stent, assessed up to 6 months
Quality of Life
time frame: From stent placement until death or placement of second stent, assessed up to 6 months.
Survival
time frame: From stent placement until death or placement of second stent, assessed up to 6 months.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Foundation for Liver Research.