Trial Information
A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recurrent dysphagia.
Outcome Description:
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.
Outcome Time Frame:
From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
Safety Issue:
No
Principal Investigator
Marco J Bruno, M.D., Prof
Investigator Role:
Study Director
Investigator Affiliation:
Erasmus Medical Center
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
COPAC
NCT ID:
NCT01661686
Start Date:
July 2012
Completion Date:
January 2015
Related Keywords:
- Esophageal Cancer
- Esophageal Stenosis
- esophageal cancer
- esophageal stenosis
- stent
- endoscopy
- Constriction, Pathologic
- Esophageal Diseases
- Esophageal Neoplasms
- Esophageal Stenosis