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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 8712 |
|---|---|
| a.m.voorburg@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, crossover multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2006 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl#http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
