Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Esophageal Cancer Esophageal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insertion of a partially covered SEMS

Group Type ACTIVE_COMPARATOR

Partially covered SEMS

Intervention Type DEVICE

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Insertion of a Fully covered SEMS

Group Type ACTIVE_COMPARATOR

Fully covered SEMS

Intervention Type DEVICE

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Interventions

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Partially covered SEMS

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Intervention Type DEVICE

Fully covered SEMS

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Intervention Type DEVICE

Other Intervention Names

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WallFlex Partially covered esophageal stent WallFlex Fully covered esophageal stent

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No