2006-12
2014-11
2014-12
92
NCT00501176
Karolinska Institutet
Karolinska Institutet
INTERVENTIONAL
Preoperative Stent Study
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2007-07-11 | N/A | 2022-06-22 |
2007-07-12 | N/A | 2022-06-29 |
2007-07-13 | N/A | 2022-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: plastic stent Stent insertion | PROCEDURE: Plastic and metalic stent inserion
|
ACTIVE_COMPARATOR: metalic stent Stent inserttion | PROCEDURE: Plastic and metalic stent inserion
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Intra-operative measurement of the Culture from the bile. | Intraoperativt |
Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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