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Preoperative Stent Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501176
Recruitment Status : Unknown
Verified June 2014 by Farshad Frozanpor, Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : July 13, 2007
Last Update Posted : June 13, 2014
Information provided by (Responsible Party):
Farshad Frozanpor, Karolinska Institutet

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.

Condition or disease Intervention/treatment
Pancreas Cancer Procedure: Plastic and metalic stent inserion

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy
Study Start Date : December 2006
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
Active Comparator: plastic stent
Stent insertion
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: metalic stent
Stent inserttion
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

Primary Outcome Measures :
  1. Intra-operative measurement of the Culture from the bile. [ Time Frame: Intraoperativt ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501176

Contact: Farshad Frozanpor

Karolinksa university hospital Recruiting
Stockholm, Sweden, 14186
Contact: Farshad Frozanpor         
Contact: Urban Arnelo         
Principal Investigator: Farshad Frozanpor         
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Farshad Frozanpor Karolinksa university hospital
Study Director: Urban Arnelo, M.D. Karolinska institut Huddinge
Study Chair: Lars Lundell, Professor Karolinska Institutet

Responsible Party: Farshad Frozanpor, MD, PhD, Karolinska Institutet Identifier: NCT00501176     History of Changes
Other Study ID Numbers: ¨2006/220-31/4
First Posted: July 13, 2007    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014

Keywords provided by Farshad Frozanpor, Karolinska Institutet:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases