Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction - Full Text View

Sponsor:	University Hospital, Linkoeping
Information provided by:	University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT00280709

Purpose

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280709

Locations

Sweden
Department of Surgery, University Hospital
Linkoping, Sweden, 58185

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

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

No publications provided by University Hospital, Linkoeping

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kullman E, Frozanpor F, Söderlund C, Linder S, Sandström 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, Gözen 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.

Responsible Party:	Eric Kullman, M.D., Associate Professor, Department of Surgery, University Hospital, Linkoping, Sweden
ClinicalTrials.gov Identifier:	NCT00280709 History of Changes
Other Study ID Numbers:	ELLA
Study First Received:	January 20, 2006
Last Updated:	August 9, 2011
Health Authority:	Sweden: Swedish National Council on Medical Ethics

Keywords provided by University Hospital, Linkoeping:

Bile duct
Bile duct obstruction
Biliary stent
Metal stent

ERCP
Patency
Complication
Stent occlusion

Additional relevant MeSH terms:

Cholestasis
Pancreatic Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms

Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Gallbladder Diseases

ClinicalTrials.gov processed this record on February 13, 2012