Post Operative Pancreatic Fistula Clinical Trial
Official title:
Pancreas Fistula After Distal Pancreatic Resection: Prevention and Treatment in a Randomized Controlled 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.
Studies have shown that reinforcement of the staple line when dividing pancreas could reduce
the risk of leakage.
Surgisis (COOK Medical) a product already in use for staple line reinforcement in gastric
and lung surgery could be used as a reinforcement when stapling pancreas in left sided
resections.
In a prospective randomized trial we want to compare Surgisis reinforcement to no
reinforcement of stapled division in left sided pancreatic resections.
Primary outcome is pancreatic fistula yes/no.
Resection of the distal pancreas is often done due to a localized tumor in the body or tail
of the pancreas. During later years the mortality after pancreatic resections have been
reduced but there still is a substantial risk of severe complications mainly due to leakage
from the pancreatic division line which could lead to suffering, longer hospital stay,
higher costs and sometimes death. Leakage from a tail resection is probably more common than
thought of before. Frequencies of above 30% and even up to 60% have been reported.
The use of somatostatin to reduce the production of pancreatic juice or comparison between
stapled division, suturing of the remaining part of the cut pancreas or covering it with
glue or available surrounding tissue have not showed significant superiority for any of
these methods except for a positive trend regarding the stapling technique. Staple line
reinforcement with resorbable mesh has in some studies showed a both negative and positive
effect on pancreatic fistula frequency. These studies have been small and non-randomized. A
larger randomized single blinded study by Hamilton et al on the other hand showed a
significant positive effect on pancreatic fistula frequency after distal pancreatic
resection using an absorbable reinforcement device put on the stapler, when only regarding
type B and C fistulas as defined by the ISGPF (International Study Group on Pancreatic
Fistula) pancreatic leak grading system.
Although all these endeavors the problem of pancreatic fistulas remain and therefore all
these operations are concluded with the deposit of one or more drains to the area of the cut
pancreas.
There is therefore of importance to continue the work of reducing complications in high risk
pancreatic surgery using scientific procedures of high quality as in blinded randomized
controlled trials (RCT). The use of reinforced stapling techniques has been used in lung
surgery and bariatric surgery to reduce air leakage and strengthen anastomoses. The material
used is processed submucosa from the small bowel of the pig, produced by COOK© Medical to
fit endoscopic staplers from Ethicon© or Covidien©.
After the promising result from Hamilton et al we plan to study if the reinforcement made by
COOK© could reduce the frequency of pancreatic fistula after stapled distal pancreatic
surgery in a single blinded RCT.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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