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| ID | Type | Description | Link |
|---|---|---|---|
| 2013/896-31/4 | Other Identifier | Swedish Ethic Committee |
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| Name | Class |
|---|---|
| Lund University Hospital | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Region Örebro County | OTHER |
| Uppsala University Hospital |
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Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. No treatment is currently available. It can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may therefore be a potentially effective treatment.
Patients surviving one year after esophagectomy are sent questionnaires to pick up symptoms suggestive of delayed gastric emptying.Those fulfilling predefined criteria for delayed gastric emptying will be invited to the study. The study design is sham controlled single blind with a follow up extending to twelve months post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mm Pyloric balloon dilatation. | Sham Comparator | During fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation. |
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| Pneumatic pyloric dilatation. | Active Comparator | Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumatic pyloric dilatation | Device |
| ||
| 15 mm pyloric balloon dilatation |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms suggestive of delayed gastric emptying | Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation. | 3-12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation. | 3-12 months after treatment. |
| Delayed gastric emptying |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Tsai, ass professor | Karolinska University Hospital, Gastrocentrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 14186 | Sweden |
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| OTHER |
| University Hospital, Linkoeping | OTHER |
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| Other |
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Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation. Paracetamol test done only 3 months after treatment. |
| 3, 6 and 12 months after treatment. |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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