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| ID | Type | Description | Link |
|---|---|---|---|
| 2011/1262-31/3 | Other Identifier | Swedish Ethic Committee |
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Terminated due to insufficient inclusion rate.
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| Name | Class |
|---|---|
| Ralf Segersvärd | UNKNOWN |
| Afshin Noorani | UNKNOWN |
| John Blomberg | UNKNOWN |
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A small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying.
Every patient submitted to a whipple resection and at the same time present with characteristics suggestive of minimal risk for leakage from the pancreaticojejunostomy will be included in the study. At the time of reconstruction the patient will be randomized to either conventional size of the stomach or to a subtotal gastrectomy containing a small upper gastric pouch only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Whipple procedure | Active Comparator | Conventional Whipple procedure |
|
| Subtotal gastrectomy added to whipple procedure. | Experimental | Subtotal gastrectomy added to Whipple procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subtotal gastrectomy as an adjunct to traditional whipple procedure. | Procedure | Subtotal gastrectomy as an adjunct to traditional whipple procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delayed gastric emptying | During the postoperative phase the patient will be followed daily with assessment of symptoms suggestive of delayed gastric emptying. | Postoperative recovery period in days (on an average <20 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life measured by use of scientifically validated instruments. | during three first postoperative months |
| Postoperative hospital stay | Time in days from the operation to discharge from hospital. |
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Inclusion Criteria:
All patients undergoing whipple procedure with preoperative assignment as low risk for leakage from the pancreaticojejunal anastomosis.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Lundell, professor | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital Gastrocentrum | Stockholm | Sweden |
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| Conventional whipple procedure | Procedure | All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage. |
|
| In hospital stay in days (on an average <20 days) |
| Total Gastric emptying as measured by the paracetamol test | Paracetamol orally ingested together with chocolate biscuits whereafter peripheral venous blood concentrations of paracetamol are determined. Blood samples taken at baseline and every 15 minutes after paracetamol ingestion during the first hour and then every 30 minutes for an hour. | three months postoperatively |