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Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction

This study has been completed.
Information provided by:
University Hospital, Linkoeping Identifier:
First received: January 20, 2006
Last updated: August 9, 2011
Last verified: December 2010
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
Bile Duct Obstruction
Pancreatic Cancer
Gallbladder Cancer
Bile Duct Cancer
Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.

Resource links provided by NLM:

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction? [ Time Frame: 12 months after stent insertion ]

Enrollment: 400
Study Start Date: January 2006
Study Completion Date: August 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Covered metal stent
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
Active Comparator: 2
Uncovered metal stent
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


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 20 years of age or older
  • 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:

  • patients with active hepatitis or other hepatic diseases that may cause jaundice
  • informed consent not obtained
  • metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria)
  • 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)
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Please refer to this study by its identifier: NCT00280709

Department of Surgery, University Hospital
Linkoping, Sweden, 58185
Sponsors and Collaborators
University Hospital, Linkoeping
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.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eric Kullman, M.D., Associate Professor, Department of Surgery, University Hospital, Linkoping, Sweden Identifier: NCT00280709     History of Changes
Other Study ID Numbers: ELLA
Study First Received: January 20, 2006
Last Updated: August 9, 2011

Keywords provided by University Hospital, Linkoeping:
Bile duct
Bile duct obstruction
Biliary stent
Metal stent
Stent occlusion

Additional relevant MeSH terms:
Pancreatic Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases processed this record on April 27, 2017