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Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy

20 Years
Open (Enrolling)
Pancreas Cancer

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Trial Information

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.

Inclusion Criteria:

- The primary inclusion criteria are all patients with operable Periampullary cancer
and jaundice who have not previously undergone bile flow drainage.

Exclusion Criteria:

- Define as failed ERCP, patients who have previously undergone bile flow drainage or
radical surgery is not possible.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Intra-operative measurement of the Culture from the bile.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Farshad Frozanpor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinksa university hospital


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

December 2006

Completion Date:

December 2013

Related Keywords:

  • Pancreas Cancer
  • Pancreas
  • cancer
  • SEMS
  • Plastic
  • stent
  • Whipple
  • Jaundicie
  • Pancreatic Neoplasms