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Preoperative Stent Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Farshad Frozanpor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00501176
First received: July 11, 2007
Last updated: June 11, 2014
Last verified: June 2014

July 11, 2007
June 11, 2014
December 2006
November 2014   (final data collection date for primary outcome measure)
Intra-operative measurement of the Culture from the bile. [ Time Frame: Intraoperativt ] [ Designated as safety issue: No ]
Intra-operative measurement of the inflammatory reaction in the liver, hepatoduodenal ligament and around the bile ducts with biopsies and Culture from the bile. [ Time Frame: Intraoperativt ]
Complete list of historical versions of study NCT00501176 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Perioperative ] [ Designated as safety issue: No ]
Stent dysfunction and cholangitis after ERCP and pre-operative bile flow relief. Postoperative complication. Time in the hospital. Cost. Quality of life analysis. [ Time Frame: postoperative ]
Not Provided
Not Provided
 
Preoperative Stent Study
Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy

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.

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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreas Cancer
Procedure: Plastic and metalic stent inserion
Patient randomizes to metal or plastic insertion prior to Whipple procedure
Other Name: Two types of Stent prior to Whipple procedure
  • Active Comparator: plastic stent
    Stent insertion
    Intervention: Procedure: Plastic and metalic stent inserion
  • Active Comparator: metalic stent
    Stent inserttion
    Intervention: Procedure: Plastic and metalic stent inserion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact: Farshad Frozanpor farshad.frozanpor@ki.se
Sweden
 
NCT00501176
¨2006/220-31/4
Yes
Farshad Frozanpor, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Farshad Frozanpor Karolinksa university hospital
Study Director: Urban Arnelo, M.D. Karolinska institut Huddinge
Study Chair: Lars Lundell, Professor Karolinska Institutet
Karolinska Institutet
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP