Cancer of Gastro Esophageal Junction, Esophageal Cancer, Palliative Treatment
Conditions
Brief 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.
Interventions
DEVICEPartially covered SEMS
DEVICEFully covered SEMS
Sponsors
Sahlgrenska University Hospital
Blekinge County Council Hospital
Danderyd Hospital
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SEMS dislocation in cm during first thirty days after stent insertion. | Thirty days from stent deployment. |
Secondary
| Measure | Time frame |
|---|---|
| Health Related Quality of Life (HRQOL) | Within three months of SEMS deployment. |
| Need for reintervention | Within three months after SEMS |
| Grade of dysphagia within three months of SEMS. | Three months after insertion. |
Countries
Sweden
Outcome results
None listed