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Sponsored by: |
University Hospital, Linkoeping |
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Information provided by: | University Hospital, Linkoeping |
ClinicalTrials.gov Identifier: | NCT00280709 |
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.
Condition | Intervention | Phase |
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Bile Duct Obstruction Pancreatic Cancer Gallbladder Cancer Bile Duct Cancer |
Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study. |
Enrollment: | 400 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | October 2009 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Covered metal stent
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Device: "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
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2: Active Comparator
Uncovered metal stent
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Device: "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
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Department of Surgery, University Hospital | |
Linkoping, Sweden, 58185 |
Study Chair: | Eric P Kullman, M.D. | Department of Surgery, University Hostpital, Linkoping, Sweden. |
Principal Investigator: | Claes Soderlund, M.D. | Department of Surgery, Sodersjukhuset, Stockholm, Sweden. |
Principal Investigator: | Bo Ohlin, M.D. | Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden. |
Principal Investigator: | Ervin Toth, M.D. | Department of Endoscopy, University Hospital MAS, Malmö, Sweden. |
Principal Investigator: | Carl-Eric Leijonmarck, M.D. | Department of Surgery, S:t Goran Hospital, Stockholm, Sweden. |
Principal Investigator: | Eduard Jonas, M.D. | Department of Surgery, Danderyd Hospital, Stockholm, Sweden. |
Principal Investigator: | Claes Rudberg, M.D. | Department of Surgery, Central Hospital, Vasteras, Sweden. |
Principal Investigator: | Kalev Teder, M.D. | Department of Surgery, Central Hospital, Norrkoping, Sweden. |
Principal Investigator: | Erik Svartholm, M.D. | Department of Surgery, Ryhov Hospital, Jonkoping, Sweden. |
Principal Investigator: | Mehmet Gozen, M.D. | Department of Surgery, Vastervik Hospital, Vastervik, Sweden. |
Responsible Party: | Department of Surgery, University Hospital, Linkoping, Sweden ( Eric Kullman, M.D., Associate Professor ) |
Study ID Numbers: | ELLA |
Study First Received: | January 20, 2006 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00280709 |
Health Authority: | Sweden: Swedish National Council on Medical Ethics |
Bile duct Bile duct obstruction Biliary stent Metal stent |
ERCP Patency Complication Stent occlusion |
Gallbladder Diseases Biliary Tract Neoplasms Digestive System Neoplasms Cholestasis Pancreatic Neoplasms Endocrine System Diseases Gall bladder cancer Digestive System Diseases |
Bile Duct Diseases Biliary Tract Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gallbladder Neoplasms Bile Duct Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |