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Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.
Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.
Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.
B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent | Active Comparator |
| |
| conventional distal pancreatectomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stent | Procedure | ERCP guided stent insertion before transection of the gland |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drain fluid content analyses | Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days. | At least 5 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent | At least 5 postoperative days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urban Arnelo | Karolinksa university hospital | Study Director |
| Farshad Frozanpor | Karolinksa university hospital | Principal Investigator |
| Lars Lundell, Professor | Karolinska Institutet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinksa university hospital | Stockholm | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22584629 | Derived | Frozanpor F, Lundell L, Segersvard R, Arnelo U. The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial. Ann Surg. 2012 Jun;255(6):1032-6. doi: 10.1097/SLA.0b013e318251610f. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D015607 | Stents |
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
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| Distal pancreatectomy | Procedure | conventional distal pancreatectomy |
|
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011859 |
| Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D019060 | Minimally Invasive Surgical Procedures |