Skip to content

Percutaneous Radiofrequent Lesioning of the Splanchnic Nerves in Patients with Chronic Pancreatitis

Percutaneous Radiofrequent Lesioning of the Splanchnic Nerves in Patients with Chronic Pancreatitis - Percutaneous RF Lesioning Splanchnic Nerves in Chronic Pancreatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35283
Enrollment
24
Registered
2010-11-17
Start date
2011-04-19
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pancreatitis

Interventions

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

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 (including opiods), with a duration of at least three months

Exclusion criteria

Exclusion criteria: Patients with pseudocysts, bile duct obstruction, duodenal obstruction or pancreatic cancer. Age younger than 18 years A noncooperative patient Coagulopathy Previous splanchnic nerve denervation Pregnancy

Design outcomes

Primary

MeasureTime frame
The percentage of reduction of pain after PRFLSN for a period of at least 6 months and preferably one year.

Secondary

MeasureTime frame
* Level of pain reduction after PRFLSN compared to optimal medical treatment * Reduction in the number of painful days per month * Reduction of medication use (NSAID*s and opioids) (MQS) * Quality of life (QLC-30, PAN-28 (chronic pancreatitis specific questionnaire), EQ-5D, BDI) * Reduction in number of man-lost days per month * Weight gain

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)