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ISRCTN
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ISRCTN20350801
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ClinicalTrials.gov identifier
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Public title
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Early Endoscopic Ultrasonography (EUS)-guided coeliac plexus neurolysis versus opioids for the treatment of pain in pancreatic carcinoma
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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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N/A
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Study hypothesis
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We want to investigate which treatment modality is better, the fentanyl patches or the Endoscopic Ultrasonography (EUS)-guided Coeliac Plexus Neurolysis (CPN). This has never been investigated before. We think that the latter treatment might be less effective than one would expect according to earlier studies.
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised, active controlled, crossover multicentre trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Pancreatic carcinoma
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Participants - inclusion criteria
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1. Cytological or histological proven irresectable pancreatic carcinoma
2. Chronic pain unresponsive to non-opioid analgesic drugs and low dose fentanyl (Durogesic®) transdermal patches (Visual Analogue Scale [VAS] score greater than three while using fentanyl transdermal patches maximum 50 ug/h, one patch per three days)
3. Age above 18 years
4. Karnovsky score greater than 30%
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Participants - exclusion criteria
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1. Previous coeliac plexus blockade
2. Use of opioids
3. Refusal to sign informed consent
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Anticipated start date
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01/08/2006
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Anticipated end date
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01/09/2008
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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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120
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Interventions
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Patients will be randomised according to two treatment algorithms. The first “conventional” type treatment algorithms consists of increasing dosages of transdermal fentanyl patches. In this algorithm, EUS-guided CPN (rescue) will only be performed in case of failure of opioid treatment because of insufficient pain relief (VAS score greater than or equal to 4) or unmanageable side effects. The second treatment algorithm consists of early (repeated) EUS-guided CPN. In case of insufficient pain relief after the second CPN, opioid treatment with transdermal fentanyl patches may be started. Adequate response to therapy (either after EUS-guided CPN or opioids) is defined as a pain score less than or equal to 3 on a scale from 0 - 10 (VAS score) and the absence of unmanageable opioid-related side effects.
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Primary outcome measure(s)
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Quality of Adjusted Life Years (QALYs) will be the primary outcome parameter. This is a composite endpoint linking survival and quality of life, i.e. the number of quality adjusted life years. These are based on biweekly assessments of health status with the EuroQoL questionnaire (EQ-5D). The utility of each observed health score profile on the EQ-5D will be derived from previous research in which the time trade off based elicitation technique during interviews with adults from the general population has been applied.
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Secondary outcome measure(s)
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1. Health-related quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ-C30])
2. Survival
3. Opioid requirement
4. Health status (EQ-5D)
5. Adverse effects
6. Costs
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Sources of funding
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Academic Medical Centre (AMC) (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
A.M.C.J.
Voorburg
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Address
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Academic Medical Centre
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 566 8712
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Email
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a.m.voorburg@amc.uva.nl
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Sponsor
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Academic Medical Centre (AMC) (The Netherlands)
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Address
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Department of Gastroenterology
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Sponsor website:
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http://www.amc.uva.nl#http://www.amc.uva.nl/
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Date applied
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27/06/2007
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Last edited
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21/09/2007
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Date ISRCTN assigned
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27/06/2007
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