Early Endoscopic Ultrasonography (EUS)-guided coeliac plexus neurolysis versus opioids for the treatment of pain in pancreatic carcinoma

ISRCTN	ISRCTN20350801
DOI	https://doi.org/10.1186/ISRCTN20350801
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Academic Medical Centre (AMC) (The Netherlands)

Submission date: 27/06/2007
Registration date: 27/06/2007
Last edited: 21/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A.M.C.J. Voorburg
Scientific

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 8712
Email	a.m.voorburg@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, crossover multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Transdermal fentanyl patches
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	120
Key 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%
Key exclusion criteria	1. Previous coeliac plexus blockade 2. Use of opioids 3. Refusal to sign informed consent
Date of first enrolment	01/08/2006
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan