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


N/A
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer, Esophageal Stenosis

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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

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