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

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

MedlinePlus related topics:

Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	400
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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

Contacts


Contact: Eric P Kullman, M.D.	+ 46 13 222000 ext 3545	eric.kullman@lio.se

Contact: Per Sandstrom, M.D.	+46 13 222000 ext 3556	per.sandstrom@lio.se

Locations


Sweden
	Department of Surgery, University Hospital	Recruiting
	Linkoping, Sweden, 58185
	Contact: Eric P Kullman, M.D. +46 13 222000 ext 3545 eric.kullman@lio.se
	Contact: Per Sandstrom, M.D. +46 13 222000 ext 3556 per.sandstrom@lio.se

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

Responsible Party:	Department of Surgery, University Hospital, Linkoping, Sweden ( Eric Kullman, M.D., Associate Professor )
Study ID Numbers:	ELLA
First Received:	January 20, 2006
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00280709
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

Study placed in the following topic categories:

Gallbladder Diseases

Digestive System Neoplasms

Biliary Tract Neoplasms

Cholestasis

Pancreatic Neoplasms

Endocrine System Diseases

Gall bladder cancer

Digestive System Diseases

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Neoplasms

Pancreatic Diseases

Endocrinopathy

Gallbladder Neoplasms

Bile Duct Neoplasms

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on August 29, 2008

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