Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis

NCT01005017 | Unknown

• 1 other identifier: 0911111
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis; Chronic Pain; Abdominal Pain

Keywords

Radiofrequent ablation; Percutaneous radiofrequent therapy

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

• Level of pain reduction after PRFLSN compared to optimal medical treatment

  3 months

Study Arms (2)

Percutanous RF lesioning

ACTIVE COMPARATOR

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

Optimal medical treatment

NO INTERVENTION

Interventions

Percutaneous Radiofrequent Lesioning PROCEDURE

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

Percutanous RF lesioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with pseudocysts, bile duct obstruction, duodenal obstruction or pancreatic cancer.
• Age younger than 18 years.
• A noncooperative patient.
• Coagulopathy.
• Pregnancy.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MaastrichUMC

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Chronic Pain; Abdominal Pain

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Yolande CA Keulemans, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolande CA Keulemans, PhD

CONTACT

0031-43-3875021; yolande_keulemans@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 26, 2011

Record last verified: 2011-07

Locations

NL (1)