Karolinksa University Hospital
Stockholm, 14186, Sweden
NCT Number: NCT00501176
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.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Stockholm, 14186, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient randomizes to metal or plastic insertion prior to Whipple procedure
Other names: Two types of Stent prior to Whipple procedure
Time frame: Intraoperativt
Time frame: Perioperative
Karolinska Institutet
Other
Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02078700
Adenoma, Digestive System Diseases
Reggio Emilia, Italy
View Trial DetailsNCT02632448
Adnexal Diseases, Breast Cancer
Boston, Massachusetts, United States
View Trial DetailsNCT05131815
Astrocytoma, Behavior
Los Angeles, California, United States
View Trial DetailsNCT02089269
Digestive System Diseases, Digestive System Neoplasms
Freiburg im Breisgau, Baden-Wurttemberg, Germany
View Trial Details