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Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.

Phase 4
20 Years
Not Enrolling
Bile Duct Obstruction, Pancreatic Cancer, Gallbladder Cancer, Bile Duct Cancer

Thank you

Trial Information

Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?

Outcome Time Frame:

12 months after stent insertion

Safety Issue:


Principal Investigator

Eric P Kullman, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Surgery, University Hostpital, Linkoping, Sweden.


Sweden: Swedish National Council on Medical Ethics

Study ID:




Start Date:

January 2006

Completion Date:

August 2010

Related Keywords:

  • Bile Duct Obstruction
  • Pancreatic Cancer
  • Gallbladder Cancer
  • Bile Duct Cancer
  • Bile duct
  • Bile duct obstruction
  • Biliary stent
  • Metal stent
  • ERCP
  • Patency
  • Complication
  • Stent occlusion
  • Cholestasis
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms