Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501176
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2007-07-11
Brief Title:
Preoperative Stent Study
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None