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

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.

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Key information

Conditions

Bile Duct Obstruction Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Cholestasis Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gallbladder Cancer Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Surgery, University Hospital

Linköping, 58185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)

Device

Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2010
First posted: Jan 23, 2006
Registry last updated: Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed