Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures
Conditions
Esophageal Cancer - Esophageal Stenosis
Conditions: official terms
Esophageal Neoplasms - Esophageal Stenosis
Conditions: Keywords
esophageal cancer, esophageal stenosis, stent, endoscopy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Partially covered SEMS Type: Device
Name: Fully covered SEMS Type: Device
Overall Status
Recruiting
Summary
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
IJsselland Hospital
Capelle a/d IJssel, Zuid Holland, Netherlands
Status: Recruiting
Contact: Tang - tjtang@ysl.nl
Ikazia Hospital
Rotterdam, Zuid Holland, Netherlands
Status: Recruiting
Contact: Ter Borg - pcj.ter.borg@ikazia.nl
Sint Fransiscus Gasthuis
Rotterdam, Zuid Holland, Netherlands
Status: Recruiting
Contact: Leeuwenburg - i.leeuwenburgh@sfg.nl
Albert Schweitzer Hospital
Zwijndrecht, Zuid Holland, Netherlands
Status: Recruiting
Contact: Wolters - L.M.M.Wolters@asz.nl
Erasmus Medical Center
Rotterdam, Netherlands
Status: Recruiting
Contact: Manon CW Spaander - v.spaander@erasmusmc.nl
Start Date
July 2012
Completion Date
June 2016
Sponsors
Foundation for Liver Research
Source
Foundation for Liver Research
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page