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Clinical Trials/NCT00501176
NCT00501176
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country92 target enrollmentDecember 2006
ConditionsPancreas Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreas Cancer
Sponsor
Karolinska Institutet
Enrollment
92
Locations
1
Primary Endpoint
Intra-operative measurement of the Culture from the bile.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Randomized study comparing the effect of plastic stents to that of expandable metal stents as pre-operative drainage of the bile ducts prior to Whipple operation.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
December 2014
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Intra-operative measurement of the Culture from the bile.

Time Frame: Intraoperativt

Secondary Outcomes

  • Intraoperative measurements of inflammatory reaction in the liver, hepatoduodenal ligament and around the bile ducts with biopsies. Stent dysfunction and cholangitis after ERCP and pre-operative bile flow relief. Postoperative analysis.(Perioperative)

Study Sites (1)

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