Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
NCT ID: NCT00280709
Last Updated: 2011-08-10
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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COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2006-01-31
2010-08-31
Brief Summary
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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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1
Covered metal stent
"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm
2
Uncovered metal stent
"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm
Interventions
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"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm
Eligibility Criteria
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Inclusion Criteria
* oral and written information given and informed consent obtained
* clinical data in accordance with malignant bile duct obstruction
* ultrasonography signs of extrahepatic malignant common bile duct obstruction
* typical radiological findings at ERCP of malignant common bile duct stenosis
* proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence
* bilirubin \> 50 micromol/L
* radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ERCP procedure, and the patient is randomized at the time of insertion of the metal stent)
Exclusion Criteria
* informed consent not obtained
* the patient is probably a candidate for surgical resection
* suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
* the proximal end of the stenosis is located within 2 cm from the hepatic confluence
* the patient has previously undergone BII or Roux-en-Y gastric resection, or has a significant duodenal obstruction making ERCP difficult
* previously (more than 4 weeks earlier) treated with a bile duct stent
* severe coagulation disturbance (PK-INR \> 1.6)
20 Years
ALL
No
Sponsors
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University Hospital, Linkoeping
OTHER
Responsible Party
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Department of Surgery, University Hospital, Linkoping, Sweden
Principal Investigators
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Eric P Kullman, M.D.
Role: STUDY_CHAIR
Department of Surgery, University Hostpital, Linkoping, Sweden.
Claes Soderlund, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Sodersjukhuset, Stockholm, Sweden.
Bo Ohlin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden.
Ervin Toth, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Endoscopy, University Hospital MAS, Malmö, Sweden.
Carl-Eric Leijonmarck, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, S:t Goran Hospital, Stockholm, Sweden.
Eduard Jonas, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Danderyd Hospital, Stockholm, Sweden.
Claes Rudberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Central Hospital, Vasteras, Sweden.
Kalev Teder, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Central Hospital, Norrkoping, Sweden.
Erik Svartholm, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Ryhov Hospital, Jonkoping, Sweden.
Mehmet Gozen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Vastervik Hospital, Vastervik, Sweden.
Locations
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Department of Surgery, University Hospital
Linköping, , Sweden
Countries
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References
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Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gozen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010 Nov;72(5):915-23. doi: 10.1016/j.gie.2010.07.036.
Other Identifiers
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ELLA
Identifier Type: -
Identifier Source: org_study_id
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