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
  Purpose

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 Intervention
Pancreas Cancer
Procedure: Plastic and metalic stent inserion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Intra-operative measurement of the Culture from the bile. [ Time Frame: Intraoperativt ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: December 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501176

Contacts
Contact: Farshad Frozanpor farshad.frozanpor@ki.se

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

No publications provided

Responsible Party: Farshad Frozanpor, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00501176     History of Changes
Other Study ID Numbers: ¨2006/220-31/4
Study First Received: July 11, 2007
Last Updated: June 11, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Pancreas
cancer
SEMS
Plastic
stent
Whipple
Jaundicie

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

ClinicalTrials.gov processed this record on July 31, 2014