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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Karolinska University Hospital

Current Primary Outcome: POPF healing time (days) [ Time Frame: 12 days (median hospital stay) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: POPF grade (A,B,C) [ Time Frame: 12 days (median hospital stay) ]

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.


Original Secondary Outcome: Same as current

Information By: Karolinska University Hospital

Dates:
Date Received: August 18, 2014
Date Started: June 2014
Date Completion: October 2017
Last Updated: August 18, 2014
Last Verified: August 2014