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

Primary Purpose

Chronic Pancreatitis, Chronic Pain, Abdominal Pain

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Percutaneous Radiofrequent Lesioning
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Radiofrequent ablation, Percutaneous radiofrequent therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MaastrichUMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Percutanous RF lesioning

Optimal medical treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Level of pain reduction after PRFLSN compared to optimal medical treatment alone as determined by numeric rating scales (NRS)

Secondary Outcome Measures

Level of pain reduction after PRFLSN compared to optimal medical treatment

Full Information

First Posted
October 29, 2009
Last Updated
July 25, 2011
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01005017
Brief Title
Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis
Acronym
PRFLSN
Official Title
Percutaneous Radiofrequent Lesioning of the Splanchnic Nerves in Patients With Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Chronic Pain, Abdominal Pain
Keywords
Radiofrequent ablation, Percutaneous radiofrequent therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutanous RF lesioning
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Optimal medical treatment
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Radiofrequent Lesioning
Intervention Description
One group receives PRFLSN after a positive trial block with bupivacaine, the other group receives no extra treatment besides optimal medical treatment.
Primary Outcome Measure Information:
Title
Level of pain reduction after PRFLSN compared to optimal medical treatment alone as determined by numeric rating scales (NRS)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Level of pain reduction after PRFLSN compared to optimal medical treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yolande CA Keulemans, PhD
Phone
0031-43-3875021
Email
yolande_keulemans@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yolande CA Keulemans, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MaastrichUMC
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolande Keulemans, PhD
Phone
00314338765021
Email
yolande.keulemans@mumc.nl
First Name & Middle Initial & Last Name & Degree
Yolande Keulemans, PhD

12. IPD Sharing Statement

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Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis

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