An interventional study of Plastic and metalic stent inserion in Pancreas Cancer, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-06-29.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's enrollment of 92 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
Stent insertion
Procedure: Plastic and metalic stent inserion
Stent inserttion
Procedure: Plastic and metalic stent inserion
Patient randomizes to metal or plastic insertion prior to Whipple procedure
Also known as: Two types of Stent prior to Whipple procedure
Intra-operative measurement of the Culture from the bile.
Time frame: Intraoperativt
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
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet