Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.
Conditions
Esophageal Cancer. - Cancer of Gastro Esophageal Junction - Palliative Treatment
Conditions: official terms
Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Partially covered SEMS Type: Device
Name: Fully covered SEMS Type: Device
Overall Status
Recruiting
Summary
Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Verified Squamous Cell Carcinoma or Adenocarcinoma of esophagus or Gastro Esophageal Junction (GEJ)

- Age above 18 years.

- Dysphagia scoring grade two or worse

- Not amenable for curative treatment

- Informed consent to participate

Exclusion Criteria:

- Concomitant cancer disease

- Inability to comply with study protocol

- Previous stent treatment

- Proximal location of the tumour in the esophagus.

- Need for more than one stent deployment.
Location
Erik Johnsson
Gothenburg, Sweden
Status: Recruiting
Contact: Magnus Nilsson, ass prof - +468585800000 - magnus.nilsson@ki.se
Start Date
October 2010
Completion Date
March 2015
Sponsors
Karolinska University Hospital
Source
Karolinska University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page