Contact information
Type
Scientific
Primary contact
Dr A.M.C.J. Voorburg
ORCID ID
Contact details
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 8712
a.m.voorburg@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, crossover multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Pancreatic carcinoma
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Transdermal fentanyl patches
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
01/08/2006
Overall trial end date
01/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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%
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
1. Previous coeliac plexus blockade
2. Use of opioids
3. Refusal to sign informed consent
Recruitment start date
01/08/2006
Recruitment end date
01/09/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list