Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis (PRFLSN)

Percutaneous Radiofrequent Lesioning of the Splanchnic Nerves in Patients With Chronic Pancreatitis

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain; Abdominal Pain; Chronic Pancreatitis
• Intervention / Treatment: Procedure: Percutaneous Radiofrequent Lesioning

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yolande CA Keulemans, PhD; Phone Number: 0031-43-3875021; Email: yolande_keulemans@hotmail.com

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202 AZ
      • Recruiting
      • MaastrichUMC
      • Contact: Yolande Keulemans, PhD; Phone Number: 00314338765021; Email: yolande.keulemans@mumc.nl
      • Principal Investigator: Yolande Keulemans, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Level of pain reduction after PRFLSN compared to optimal medical treatment alone as determined by numeric rating scales (NRS)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Level of pain reduction after PRFLSN compared to optimal medical treatment	3 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Yolande CA Keulemans, PhD, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Estimate): July 26, 2011
• Last Update Submitted That Met QC Criteria: July 25, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Radiofrequent ablation; Percutaneous radiofrequent therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pancreatic Diseases; Chronic Pain; Abdominal Pain; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 0911111