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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plastic stent | Active Comparator | Stent insertion |
|
| metalic stent | Active Comparator | Stent inserttion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plastic and metalic stent inserion | Procedure | Patient randomizes to metal or plastic insertion prior to Whipple procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative measurement of the Culture from the bile. | Intraoperativt |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Perioperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Enochsson, MD, PhD | Karolinksa Institutet | Principal Investigator |
| Urban Arnelo, M.D. | Karolinska Institutet | Study Director |
| Lars Lundell, Professor | Karolinska Institutet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinksa University Hospital | Stockholm | 14186 | Sweden |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010969 | Plastics |
| ID | Term |
|---|---|
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
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|
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013676 | Technology, Industry, and Agriculture |