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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
  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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005017

Contacts
Contact: Yolande CA Keulemans, PhD 0031-43-3875021 yolande_keulemans@hotmail.com

Locations
Netherlands
MaastrichUMC Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Yolande Keulemans, PhD    00314338765021    yolande.keulemans@mumc.nl   
Principal Investigator: Yolande Keulemans, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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
Chronic Pain
Pancreatitis
Pancreatitis, Chronic
Digestive System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Pancreatic Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 27, 2014