Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis

NCT ID: NCT01005017

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

Chronic Pancreatitis; Chronic Pain; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous Radiofrequent Lesioning

Intervention Type: PROCEDURE

One group receives PRFLSN after a positive trial block with bupivacaine, the other group receives no extra treatment besides optimal medical treatment.

Optimal medical treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Department of Gastroenterology Maastricht University Medical Center

Principal Investigators

Yolande CA Keulemans, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

MaastrichUMC

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Yolande CA Keulemans, PhD

Role: CONTACT

yolande_keulemans@hotmail.com

0031-43-3875021

Facility Contacts

Yolande Keulemans, PhD

Role: primary

yolande.keulemans@mumc.nl

00314338765021

Other Identifiers

0911111

Identifier Type: -

Identifier Source: org_study_id