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| ID | Type | Description | Link |
|---|---|---|---|
| 2009/1034-31/3 | Other Identifier | Ethical Review board, Karolinska Institute Stockholm |
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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Blekinge County Council Hospital | OTHER |
| Danderyd Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partially covered SEMS | Active Comparator | Boston Scientific Ultraflex SEMS |
|
| Fully covered SEMS | Experimental | Boston Scientific Wallflex Esophageal SEMS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partially covered SEMS | Device |
| ||
| Fully covered SEMS |
| Measure | Description | Time Frame |
|---|---|---|
| SEMS dislocation in cm during first thirty days after stent insertion. | Thirty days from stent deployment. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Johnsson, MdPhd | Sahlgrenska University Hospital, Clinic of Surgery | Principal Investigator |
| Magnus Nilsson, ass professor | Karolinska University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erik Johnsson | Gothenburg | 41345 | Sweden |
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|
| Three months after insertion. |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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