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ISRCTN
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ISRCTN02258149
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ClinicalTrials.gov identifier
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Public title
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The value of plugging percutaneous biliary drain tracts following drain removal.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0050153127
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Study hypothesis
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1. Does the use of medical collagen ('LYOSTYPT') stop bile leak following removal of percutaneous biliary drains?
2. Does the prevention of bile leak lead to a decrease in complications such as pain, fever and raised inflammatory markers?
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Obstructive jaundice
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Participants - inclusion criteria
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Patients already identified as requiring radiological intervention for life threatening biliary obstruction.
Once external biliary drainage is established patients will be approached to ask if they want to take part in the trial.
If they agree to participate in the study they will be randomised in to tract plugging or no tract plugging.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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11/10/2004
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Anticipated end date
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01/07/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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30 patients: 15 patients will be recruited for the tract plugging process and 15 for the non tract plugging.
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Interventions
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Patients with obstructive jaundice not amenable to endoscopic treatment (primary investigation and treatment modality) referred for:
PTC (Percutaneous transhepatic cholangiography)
+/ - External percutaneous drain
+/ - Internal Drainage (stent) as a one stage procedure.
Wait for bilirubin to fall, temperature to settle and biliary tree to decompress. Patients re-attend the radiology department for drain removal.
Randomisation to drain tract plugged with collagen or drain not plugged.
Follow up on ward by research nurses days 1, 2, 3 & 5. (both groups)
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Primary outcome measure(s)
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1. Pain score after drain removal
2. Complication rate
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Bradford Teaching Hospitals NHS Foundation Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Clive
Kay
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Address
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Radiology Department
Bradford Royal Infirmary
Duckworth Lane
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City/town
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Bradford
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Zip/Postcode
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BD9 6RJ
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Country
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United Kingdom
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Tel
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+44 (0)1274 364321
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Fax
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+44 (0)1274 364661
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Email
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kaycl44@hotmail.com
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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23/08/2011
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Date ISRCTN assigned
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30/09/2005
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