Biliary Metal Stent Study: Metal Stents For Management Of Distal Malignant Biliary Obstruction

Study Overview

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.

N/A

Bile Duct Obstruction
Pancreatic Cancer
Gallbladder Cancer
Bile Duct Cancer

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

ELLA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-01-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-08-09
First Submitted that Met QC Criteria 2006-01-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-08-10
First Posted (ESTIMATED) 2006-01-23	Results First Posted N/A	Last Verified 2010-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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

Participant Group/Arm

Intervention/Treatment

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

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Eric P Kullman, M.D., Department of Surgery, University Hostpital, Linkoping, Sweden.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gozen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010 Nov;72(5):915-23. doi: 10.1016/j.gie.2010.07.036.

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Resources

PatientS

Caregivers

Clinical Trial Record