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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00031860 | Other Identifier | German Clinical Trials Register |
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Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date.
Therefore the overall study aims are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatectomy | Other | Patients who underwent pancreatectomy will be enrolled. Serum amylase and lipase will be measured preoperatively. During surgery, blood samples will be taken after completing the pancreatic anastomosis and at the end of the operation during skin suture. Patients will be followed up during hospital stay, 3 and 6 months after discharge. The clinical outcome (complications, rescue pancreatectomy) will be recorded and analysed. Postoperative blood samples, according to clinical standard, will be taken at the 1, 2, 3, 5 and 7 day postoperatively. In addition to amylase several more parameters will be examined intra- and postoperatively: leucocytes, lipase, CRP, bilirubin, transaminases, AP, GGT, creatinine, interleukin-6, PCT. Intraoperative 1-2ml of pancreas juice will be taken for the evaluation of amylase and lipase levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PPAP (Postpancreatectomy Acute Pancreatitis) | Incidence after pancreasresection (pancreatoduodenectomy and distal pancreas resection) according to the definition of ISGPS (International Study Group on Pancreatic Surgery) | 90 days after surgery |
| Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia) | Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI) | 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy | Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia | 90 days after surgery |
| Correlation between hyperamylasemia and radiological findings for pancreatitis |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing a pancreatic resection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Radulova-Mauersberger, Dr. med. | Contact | +49 351 458-0 | studienzentrum-vtg@ukdd.de |
| Name | Affiliation | Role |
|---|---|---|
| Marius Distler, Prof. Dr. | University Hospital Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery | Recruiting | Dresden | 01307 | Germany |
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| ID | Term |
|---|---|
| D034321 | Hyperamylasemia |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010180 | Pancreatectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Incidence of pancreatitis according to the CT scan postoperatively |
| 90 days after surgery |
| Incidence of postoperative mortality | Postoperative death after complications | 90 days after surgery |