Healing Time of Post Operative Pancreatic Fistulas Clinical Trial
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 Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment