Esophageal Cancer Clinical Trial
— StentMigOfficial title:
The Importance of Stent Design
Verified date | January 2017 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Swedish Research Council |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | April 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Erik Johnsson | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Blekinge County Council Hospital, Danderyd Hospital, Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SEMS dislocation in cm during first thirty days after stent insertion. | Thirty days from stent deployment. | Yes | |
Secondary | Health Related Quality of Life (HRQOL) | Within three months of SEMS deployment. | Yes | |
Secondary | Need for reintervention | Within three months after SEMS | Yes | |
Secondary | Grade of dysphagia within three months of SEMS. | Three months after insertion. | Yes |
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