Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy
Patients suffering from a locally invasive tumour process in the Periampullary area usually
seek medical attention because of jaundice. Not only do patients suffering from jaundice
show significant symptoms of exhaustion and purities, but they are also at higher risk for
developing post-operative complications. Experimentally, the liver exhibits a reduced
capacity for tolerating ischemia in the presence of jaundice. Several different etiologic
factors suggest cause complication such as presence of toxic substances as bilirubin and
bile salts, impaired nutritional status, effects of endotoxins, bacterial translocation,
modulation of the inflammatory cascade with cytokine release, reduction of cellular immunity
and nutritional. These complications primarily consist of septic complications
(cholangitis, abscesses, and leakage), haemorrhage, impaired wound healing and renal
disorders. Summarily, these issues have motivated pre-operative bile flow drainage by way of
stent. Traditionally, pre-operative bile flow drainage has been achieved by insertion of a
EP because these are considered easy to remove and cause less tissue reaction in the bile
ducts. However, multiple studies have found the disadvantage with the EP is that it provides
poorer bile drainage than the SEMS.
In palliative situations, metal stents have been associated with fewer side-effects in the
form of fever relapse of jaundice, etc. These effects are likely due to better bile flow
through the stent. It remains unclear if metal stents can provide similar advantages in the
curative situation.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intra-operative measurement of the Culture from the bile.
Intraoperativt
No
Farshad Frozanpor
Principal Investigator
Karolinksa university hospital
Sweden: Regional Ethical Review Board
ยจ2006/220-31/4
NCT00501176
December 2006
December 2013
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