Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
NCT ID: NCT03350763
Last Updated: 2021-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-11-18
2025-12-31
Brief Summary
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This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Plastic biliary stent
A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression
Tannenbaum 10 Fr biliary stent
Tannenbaum 10 Fr biliary stent
Self-expandable metallic biliary stent
A self-expandable metallic biliary stent is used to achieve biliary decompression
Self-expandable metallic biliary stent
ie WallFlex biliary RX
Interventions
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Tannenbaum 10 Fr biliary stent
Tannenbaum 10 Fr biliary stent
Self-expandable metallic biliary stent
ie WallFlex biliary RX
Eligibility Criteria
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Inclusion Criteria
* Elevated serum bilirubin levels
* Radiologically visible dilatation of the biliary system
Exclusion Criteria
* Inoperable tumor or other reason, why the patient is unfit for surgery
18 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Leena Kylanpaa
Head of department
Principal Investigators
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Leena Kylänpää, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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Helsinki University Hospital
Helsinki, Uusimaa, Finland
Countries
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References
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Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4.
Haapamaki C, Seppanen H, Udd M, Juuti A, Halttunen J, Kiviluoto T, Siren J, Mustonen H, Kylanpaa L. Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent. Scand J Surg. 2015 Jun;104(2):79-85. doi: 10.1177/1457496914543975. Epub 2014 Jul 15.
Velanovich V, Kheibek T, Khan M. Relationship of postoperative complications from preoperative biliary stents after pancreaticoduodenectomy. A new cohort analysis and meta-analysis of modern studies. JOP. 2009 Jan 8;10(1):24-9.
Other Identifiers
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HUS/2470/2017
Identifier Type: -
Identifier Source: org_study_id
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