An interventional study of Percutaneous Radiofrequent Lesioning in Chronic Pancreatitis, Chronic Pain and Abdominal Pain, sponsored by Maastricht University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-26.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
Chronic pancreatitis is a progressive inflammatory disease resulting in slow destruction of the pancreas. This chronic inflammation can lead to chronic abdominal pain which can last for many years. Unfortunately, medical management often is of only limited benefit in treating the pain of chronic pancreatitis.
Management of patients with intractable pain is difficult, often resulting in narcotic addiction.
Early results in a small group of patients suggest that percutaneous radiofrequent lesioning of splanchnic nerves has good potential for pain control in a subset of patients with chronic pancreatitis. Given the simplicity of the procedure, it clearly warrants reappraisal to identify its current role in pancreatic pain management.
Rationale: Pain control is the most pressing problem in patients with chronic pancreatitis. Many methods have been advocated to control this pain. Unfortunately, these methods fail to control the pain in 20-50% of patients. Management of patients with intractable pain is difficult, often resulting in narcotic addiction. Percutaneous alcoholic block of the celiac plexus is, because of the risks of paralysis and catastrophic haemorrhage resulting from injury to major abdominal vasculature, restricted to patients with intractable, severe pain due to terminal pancreatic cancer. Splanchnic nerve lesioning is a useful alternative to celiac plexus block in the management of patients with chronic upper abdominal pain. The predictable relationship of the splanchnic nerves to other structures allows for accurate needle placement and hence a low risk of damage. Radiofrequent lesioning uses a high frequency alternating current to heat tissues leading to thermal coagulation. It produces predictable and accurate lesions.
Objective: To evaluate the feasibility and efficacy of percutaneous radiofrequent lesioning of splanchnic nerves (PRFLSN) in patients with pain caused by chronic pancreatitis. The primary goal is to determine if a 50% reduction in pain can be achieved for at least 3 months. Secondary objectives are reduction of medication use and improvement of quality of life.
Design: Single blind, prerandomized intervention study. Study population: Patients with pain (NRS>5) caused by chronic pancreatitis, despite optimal medical treatment.
Intervention: One group receives PRFLSN after a positive trial block with bupivacaine, the other group receives no extra treatment besides optimal medical treatment.
Main study endpoints: The percentage of reduction of pain after PRFLSN for a period of at least 3 months and preferably one year.
751 studies on the registry are indexed under Pancreatitis; 180 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.
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Radiofrequent lesioning uses a high frequency alternating current to heat tissues leading to thermal coagulation. It produces predictable and accurate lesions of the splanchnic nerves.
Procedure: Percutaneous Radiofrequent Lesioning
One group receives PRFLSN after a positive trial block with bupivacaine, the other group receives no extra treatment besides optimal medical treatment.
Level of pain reduction after PRFLSN compared to optimal medical treatment alone as determined by numeric rating scales (NRS)
Time frame: 3 months
Level of pain reduction after PRFLSN compared to optimal medical treatment
Time frame: 3 months
This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center