Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
This study has been completed.
Sponsor:
University Hospital, Linkoeping
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00280709
First received: January 20, 2006
Last updated: August 9, 2011
Last verified: December 2010
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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 4 |
| 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:
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):
| 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 June 17, 2013