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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR989 |
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Date of registration:
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30/05/2007 |
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Primary sponsor: |
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Public title:
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Early EUS-guided celiac plexus neurolysis versus opioids for the treatment of pain in pancreatic carcinoma
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Scientific title:
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Early EUS-guided celiac plexus neurolysis versus opioids for the treatment of pain in pancreatic carcinoma -
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Date of first enrolment:
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1/8/2006 |
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Target sample size:
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120 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=989 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Crossover; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A. M.C.J.
Voorburg |
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Address:
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, Academic Medical Center
Meibergdreef 9
1100DD
Amsterdam
The Netherlands |
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Telephone:
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+31 205668712 |
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Email:
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a.m.voorburg@amc.uva.nl |
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Affiliation:
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Name:
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A. M.C.J.
Voorburg |
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Address:
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, Academic Medical Center
Meibergdreef 9
1100DD
Amsterdam
The Netherlands |
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Telephone:
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+31 205668712 |
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Email:
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a.m.voorburg@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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 (VAS score >3 (figure 2)while using fentanyl transdermal patches maximum 50 ìg/h, 1 patch per 3 days);
3. Age above 18 years;
4. Karnovsky score >30 % (see table3)
Exclusion criteria: 1. Previous celiac plexus blockade;
2. Use of opioids;
3. Refusal to sign informed co
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Pain, Pancreatic cancer, Analgesic therapy, Celiac plexus neurolysis, Endosonography, Opioids
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Intervention(s)
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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 >=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 <= 3 on a scale from 0-10 (VAS score) and the absence of unmanageable opioid-related side effects.
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Primary Outcome(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 EQ-5D questionnaire. 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(s)
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1. Health-related quality of life (EORTC-QLQ-C30)(see table 2)
2. Survival
3. Opioid requirement
4. Health status (EQ-5D)(table 1 and figure 3)
5. Adverse effects
6. Costs
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Secondary ID(s)
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ISRCTN20350801
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Department of Gastroenterology
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