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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01005017
First received: October 29, 2009
Last updated: July 25, 2011
Last verified: July 2011

October 29, 2009
July 25, 2011
February 2011
February 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01005017 on ClinicalTrials.gov Archive Site
Level of pain reduction after PRFLSN compared to optimal medical treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Chronic Pancreatitis
  • Chronic Pain
  • Abdominal Pain
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.
  • 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.
    Intervention: Procedure: Percutaneous Radiofrequent Lesioning
  • No Intervention: Optimal medical treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Yolande CA Keulemans, PhD 0031-43-3875021 yolande_keulemans@hotmail.com
Netherlands
 
NCT01005017
0911111
No
Dr. YCA Keulemans, Department of Gastroenterology Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Yolande CA Keulemans, PhD Maastricht University Medical Center
Maastricht University Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP