Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.

Karolinska University Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Esophageal Cancer Cancer of Gastro Esophageal Junction Palliative Treatment

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

SEMS dislocation in cm during first thirty days after stent insertion.

Time frame: Thirty days from stent deployment.

Secondary Outcomes

Health Related Quality of Life (HRQOL)

Time frame: Within three months of SEMS deployment.

Need for reintervention

Time frame: Within three months after SEMS

Grade of dysphagia within three months of SEMS.

Time frame: Three months after insertion.