Early EUS-guided celiac plexus neurolysis versus opioids for the treatment of pain in pancreatic carcinoma
Recruiting
- Conditions
- pancreatic cancer, pain, opioids, analgesic therapy, celiac plexus neurolysis, endosonographypancreascarcinoom, morfine, analgetica, plexus coeliacus blokkade, endo-echo
- Registration Number
- NL-OMON28425
- Lead Sponsor
- A.VoorburgMD, gastroenterologist.Academical Medical Center AmsterdamThe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 1. Health-related quality of life (EORTC-QLQ-C30)(see table 2)<br>2. Survival<br>3. Opioid requirement<br>4. Health status (EQ-5D)(table 1 and figure 3)<br>5. Adverse effects<br>6. Costs<br>