Percutaneous Radiofrequent Lesioning of the Splanchnic Nerves in Patients with Chronic Pancreatitis
Completed
- Conditions
- Chronic pancreatitis10017969
- Registration Number
- NL-OMON35283
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Patients with chronic pancreatitis presenting with significant abdominal pain of pancreatic origin. Pain will be considered significant if there is at least 1 episode of pain every month requiring analgesics during the preceding 3 months, or at least 1 episode of severe pain requiring hospitalization in the preceding 3 months.
*Pancreatic pain (NRS-score >5 out of 10), resistant to medical therapy (including opiods), with a duration of at least three months
Exclusion Criteria
Patients with pseudocysts, bile duct obstruction, duodenal obstruction or pancreatic cancer.
Age younger than 18 years
A noncooperative patient
Coagulopathy
Previous splanchnic nerve denervation
Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percentage of reduction of pain after PRFLSN for a period of at least 6<br /><br>months and preferably one year. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Level of pain reduction after PRFLSN compared to optimal medical treatment<br /><br>* Reduction in the number of painful days per month<br /><br>* Reduction of medication use (NSAID*s and opioids) (MQS)<br /><br>* Quality of life (QLC-30, PAN-28 (chronic pancreatitis specific<br /><br>questionnaire), EQ-5D, BDI)<br /><br>* Reduction in number of man-lost days per month<br /><br>* Weight gain</p><br>