Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
|ClinicalTrials.gov Identifier: NCT00500968|
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : April 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer Fistula||Procedure: stent Procedure: Distal pancreatectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
|Active Comparator: Stent||
ERCP guided stent insertion before transection of the gland
Other Name: ERCP
|Active Comparator: conventional distal pancreatectomy||
Procedure: Distal pancreatectomy
conventional distal pancreatectomy
Other Name: surgery
- Drain fluid content analyses [ Time Frame: At least 5 postoperative days ]Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.
- 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 [ Time Frame: At least 5 postoperative days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500968
|Karolinksa university hospital|
|Stockholm, Sweden, 14186|
|Study Director:||Urban Arnelo||Karolinksa university hospital|
|Principal Investigator:||Farshad Frozanpor||Karolinksa university hospital|
|Study Chair:||Lars Lundell, Professor||Karolinska Institutet|