Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

Study Overview
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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

Official Title
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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

Conditions
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Esophageal Cancer, Esophageal Stenosis

Intervention / Treatment
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* Device: Partially covered SEMS
* Device: Fully covered SEMS


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insertion of a partially covered SEMS<br> | Device: Partially covered SEMS<br>* Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available<br>* Other names: WallFlex Partially covered esophageal stent;|
| Active Comparator: Insertion of a Fully covered SEMS<br> | Device: Fully covered SEMS<br>* Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available<br>* Other names: WallFlex Fully covered esophageal stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Recurrent Dysphagia. | 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. | From stent placement (t=0) until death or placement of second stent, assessed up to 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Technical Success of SEMS Placement | Technical succes was defined as succesful deployment of the stent which bridges the stricture | At stent placement (t=0) | 
| Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score | Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up. Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months | From stent placement until death or placement of second stent, assessed up to 6 months. | 
| Number of Participants in Whom a Major Complication Has Occured | A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula. | From stent placement until death or placement of second stent, assessed up to 6 months | 
| Median Survival After SEMS Placement | Survival from stent placement until death or placement of second stent | From stent placement until death or placement of second stent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, esophageal cancer, esophageal stenosis, endoscopy