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ISRCTN
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ISRCTN13044540
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ClinicalTrials.gov identifier
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Public title
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Prospective, randomised, single-blind study for validation of the effect of endoscopic stent implantation and drainage on patients with chronic pancreatitis and pancreas duct stenosis
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Scientific title
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Acronym
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PAGASTE
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Serial number at source
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N/A
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Study hypothesis
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The background is the already aged obstruction hypothesis. It is assumed that a relevant stricture of the pancreatic duct leads to retention and stasis of the pancreatic juice thereby mitigating pain and inflammation. If the stent achieves a drainage the frequency of episodes of pain and inflammation should be significantly reduced.
Please note that as of 08/09/09 the contact address and ethics approval have been updated. Please also note that the end date of this trial has been extended from 01/04/07 to 31/12/2010.
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Lay summary
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Ethics approval
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Added 08/09/09: Received from Leipzig Medical Faculty ethics committee, University of Leipzig on the 14th of April 2004
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Chronic pancreatitis with pancreatic duct stenosis
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Participants - inclusion criteria
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1. Chronic pancreatitis with evidence of magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)
pancreatic duct stricture (>50%) in pancreatic head
2. Chronic recurrent pain
3. Age >18, <75, WIC
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Participants - exclusion criteria
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1. Radiation of upper abdominal or lower chest area
2. Uncured cancer or systemic chemotherapy within last 5 years
3. Failure of compliance
4. Foreseeable
pregnancy
5. Participation in other therapeutic trials within last 30 days
6. Patients continuous free of symptoms
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Anticipated start date
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01/05/2004
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Anticipated end date
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31/12/2010
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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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40
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Interventions
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Endoscopic stenting of the pancreatic duct, stent exchange after 3 months versus conservative treatment with analgesics
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Primary outcome measure(s)
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Total pain score during first 3 month after ERCP, specialised Pancreas Pain Questionaire checked for reliability and validity
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Secondary outcome measure(s)
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1. Use af analgesics
2. Frequency of pain episodes within one year
3. Treatment failure
4. Signs of endocrine/exocrine failure
5. Change of diameter of pancreatic duct during treatment
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Sources of funding
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University of Leipzig (Germany)
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Trial website
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Publications
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Contact name
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Prof
Volker
Keim
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Address
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Liebigstrasse 20
Medical Clinic for Gastroenterology and Rheumatology (Medizinische Klinik für Gastroenterologie und Rheumatologie)
University Hospital Leipzig (Universitätsklinikum Leipzig AöR)
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City/town
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Leipzig
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Zip/Postcode
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04103
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Country
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Germany
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Tel
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+49 (0)3419712233
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Fax
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+49 (0)3419712209
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Email
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keimv@medizin.uni-leipzig.de
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Sponsor
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University of Leipzig (Germany)
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Address
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Liebigstrasse 20
Department of Surgery II
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City/town
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Leipzig
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Zip/Postcode
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04103
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Country
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Germany
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Date applied
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20/09/2005
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Last edited
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08/09/2009
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Date ISRCTN assigned
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21/10/2005
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