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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
N/A
Not Enrolling
Both
Bile Duct Obstruction, Pancreatic Cancer, Gallbladder Cancer, Bile Duct Cancer

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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:

Interventional

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:

Yes

Principal Investigator

Eric P Kullman, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Surgery, University Hostpital, Linkoping, Sweden.

Authority:

Sweden: Swedish National Council on Medical Ethics

Study ID:

ELLA

NCT ID:

NCT00280709

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

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