Sponsor study identifier
interventional
400
1 country
1
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)Study Completion
August 2010
Actual (reported)The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
January 20, 2006
Actual (reported)January 23, 2006
Actual (reported)October 2008
Actual (reported)August 2010
Actual (reported)Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?
12 months after stent insertion
Covered metal stent
Uncovered metal stent
Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Surgery, University Hospital
Linköping, 58185, Sweden
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.
Eric P Kullman, M.D.
Department of Surgery, University Hostpital, Linkoping, Sweden.
Claes Soderlund, M.D.
Department of Surgery, Sodersjukhuset, Stockholm, Sweden.
Bo Ohlin, M.D.
Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden.
Ervin Toth, M.D.
Department of Endoscopy, University Hospital MAS, Malmö, Sweden.
400 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2006
First Posted
January 23, 2006
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Carl-Eric Leijonmarck, M.D.
Department of Surgery, S:t Goran Hospital, Stockholm, Sweden.
Eduard Jonas, M.D.
Department of Surgery, Danderyd Hospital, Stockholm, Sweden.
Claes Rudberg, M.D.
Department of Surgery, Central Hospital, Vasteras, Sweden.
Kalev Teder, M.D.
Department of Surgery, Central Hospital, Norrkoping, Sweden.
Erik Svartholm, M.D.
Department of Surgery, Ryhov Hospital, Jonkoping, Sweden.
Mehmet Gozen, M.D.
Department of Surgery, Vastervik Hospital, Vastervik, Sweden.
Primary Completion
October 2008
Actual (reported)Study Completion
August 2010
Actual (reported)Last Updated
August 10, 2011
Record last verified: 2010-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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