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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00280709 |
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Date of registration:
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20/01/2006 |
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Primary sponsor: |
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Public title:
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Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
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Scientific title:
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Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study. |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00280709 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Ervin Toth, M.D. |
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Address:
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Affiliation:
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Department of Endoscopy, University Hospital MAS, Malmö, Sweden. |
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Name:
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Bo Ohlin, M.D. |
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Affiliation:
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Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden. |
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Name:
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Kalev Teder, M.D. |
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Affiliation:
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Department of Surgery, Central Hospital, Norrkoping, Sweden. |
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Name:
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Claes Rudberg, M.D. |
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Address:
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Affiliation:
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Department of Surgery, Central Hospital, Vasteras, Sweden. |
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Name:
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Eduard Jonas, M.D. |
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Affiliation:
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Department of Surgery, Danderyd Hospital, Stockholm, Sweden. |
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Name:
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Erik Svartholm, M.D. |
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Affiliation:
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Department of Surgery, Ryhov Hospital, Jonkoping, Sweden. |
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Name:
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Carl-Eric Leijonmarck, M.D. |
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Affiliation:
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Department of Surgery, S:t Goran Hospital, Stockholm, Sweden. |
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Name:
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Claes Soderlund, M.D. |
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Address:
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Affiliation:
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Department of Surgery, Sodersjukhuset, Stockholm, Sweden. |
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Name:
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Eric P Kullman, M.D. |
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Affiliation:
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Department of Surgery, University Hostpital, Linkoping, Sweden. |
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Name:
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Mehmet Gozen, M.D. |
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Affiliation:
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Department of Surgery, Vastervik Hospital, Vastervik, Sweden. |
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Key inclusion & exclusion criteria
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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)
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bile Duct Cancer
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Bile Duct Obstruction
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Gallbladder Cancer
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Pancreatic Cancer
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Intervention(s)
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Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
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Primary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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