Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures (COPAC)

Foundation for Liver Research

Status: Completed

Conditions: Esophageal Stenosis; Esophageal Cancer

Treatments: Device: Fully covered SEMS; Device: Partially covered SEMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01661686

COPAC

Details and patient eligibility

About

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

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Insertion of a partially covered SEMS

Active Comparator group

Treatment:

Device: Partially covered SEMS

Insertion of a Fully covered SEMS

Active Comparator group

Treatment:

Device: Fully covered SEMS