Does Post Operative Pancreatic Fistula, After Left Sided Resections, Heal Faster After the Introduction of a Pancreatic Stent?

Study Overview
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Brief Summary
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Dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage reduces healing time. A pancreatic stent could theoretically improve the drainage of pancreatic juice into the duodenum and by this shorten the healing time still further. Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not shown a positive effect on fistula formation. In an open randomized multicenter clinical trial we want to test the hypothesis that a reduced fistula healing time, in left sided pancreatic resections, could be reduced by introducing a pancreatic stent when on post operative day 3 or later a B och C fistula (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by randomizing between pancreatic stent with drains versus only drains.

Official Title
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Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial

Conditions
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Healing Time of Post Operative Pancreatic Fistulas

Intervention / Treatment
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* Device: Pancreatic stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Left sided or distal pancreatic resection Grade B or C fistula on postoperative day 3 or later Exclusion Criteria: Do not want to participate in study Can not read patient information in swedish The papilla can not be endoscopically reached

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pancreatic stent<br>If POPF grade B or C is detected on post operative day 3 or more, a pancreatic stent is endoscopically positioned in the pancreatic duct. | Device: Pancreatic stent<br>* The plastic stent is introduced in the pancreatic duct by a duodenoscope<br>* Other names: Pancreatic duct stent (made of plastic material);|
| No Intervention: Drain only<br>If POPF grade B or C is detected on post operative day 3 or more, only the per-operatively placed drain is used as treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POPF healing time (days) | Post operative pancreatic fistula(POPF) and grade (A,B,C) is diagnosed according to ISGPF on post operative day 3 or later if the pancrease-amylase concentration is more than three times the upper limit of the normal plasma concentration of pancreas-amylase. When the drain fluid concentration is below this value the fistula is defined as healed. | 12 days (median hospital stay) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POPF grade (A,B,C) | International Study Group on Pancreatic Fistula (ISGPF) (Bassi et al 2005)defines fistula grade A-C. Grade A is leakage of pancreatic juice with a concentration of more than 3 times the upper normal level in plasma but no other clinical implication for the patient. If an inflammatory response is seen, but not sepsis, it is graded as B fistula and if sepsis occurs and/or single- or multi-organ dysfunction is seen it is graded as C. | 12 days (median hospital stay) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post operative pancreatic fistulas, Pancreatic stenting