Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Study Overview
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Brief Summary
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Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Detailed Description
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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.

Official Title
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Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Conditions
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Pancreas Cancer, Fistula

Intervention / Treatment
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* Procedure: stent
* Procedure: Distal pancreatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate. Exclusion Criteria: The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stent<br> | Procedure: stent<br>* ERCP guided stent insertion before transection of the gland<br>* Other names: ERCP;|
| Active Comparator: conventional distal pancreatectomy<br> | Procedure: Distal pancreatectomy<br>* conventional distal pancreatectomy<br>* Other names: surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fistula, Pancreas, Leakage, tail