Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis (PRFLSN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01005017|
Recruitment Status : Unknown
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted : October 30, 2009
Last Update Posted : July 26, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pancreatitis Chronic Pain Abdominal Pain||Procedure: Percutaneous Radiofrequent Lesioning||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Percutaneous Radiofrequent Lesioning of the Splanchnic Nerves in Patients With Chronic Pancreatitis|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||December 2013|
Active Comparator: Percutanous RF lesioning
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.
|No Intervention: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005017
|Contact: Yolande CA Keulemans, PhDfirstname.lastname@example.org|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Contact: Yolande Keulemans, PhD 00314338765021 email@example.com|
|Principal Investigator: Yolande Keulemans, PhD|
|Principal Investigator:||Yolande CA Keulemans, PhD||Maastricht University Medical Center|