Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis (PRFLSN)
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Purpose
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 | Intervention |
|---|---|
|
Chronic Pancreatitis Chronic Pain Abdominal Pain |
Procedure: Percutaneous Radiofrequent Lesioning |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Percutaneous Radiofrequent Lesioning of the Splanchnic Nerves in Patients With Chronic Pancreatitis |
- Level of pain reduction after PRFLSN compared to optimal medical treatment alone as determined by numeric rating scales (NRS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Level of pain reduction after PRFLSN compared to optimal medical treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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, 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.
- Pregnancy.
Contacts and Locations| Contact: Yolande CA Keulemans, PhD | 0031-43-3875021 | yolande_keulemans@hotmail.com |
| Netherlands | |
| MaastrichUMC | Recruiting |
| Maastricht, Limburg, Netherlands, 6202 AZ | |
| Contact: Yolande Keulemans, PhD 00314338765021 yolande.keulemans@mumc.nl | |
| Principal Investigator: Yolande Keulemans, PhD | |
| Principal Investigator: | Yolande CA Keulemans, PhD | Maastricht University Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. YCA Keulemans, Department of Gastroenterology Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01005017 History of Changes |
| Other Study ID Numbers: | 0911111 |
| Study First Received: | October 29, 2009 |
| Last Updated: | July 25, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Maastricht University Medical Center:
|
Radiofrequent ablation Percutaneous radiofrequent therapy |
Additional relevant MeSH terms:
|
Abdominal Pain Pancreatitis Pancreatitis, Chronic Pain |
Signs and Symptoms Signs and Symptoms, Digestive Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013