To evaluate the feasibility and efficacy of percutaneous radiofrequent lesioning of splanchic 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…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of reduction of pain after PRFLSN for a period of at least 6
months and preferably one year.
Secondary outcome
* 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
Background summary
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 resulting from a transverse myelopathy 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 iatrogenic damage.
Radiofrequent lesioning uses a high frequency alternating current to heat
tissues leading to thermal coagulation. It produces predictable and accurate
lesions.
Study objective
To evaluate the feasibility and efficacy of percutaneous radiofrequent
lesioning of splanchic 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 6 months. Secondary objectives are reduction of opioid
use and improvement of quality of life.
Study design
Single blind, intervention study.
Intervention
One group receives PRFLSN after a positive trial block with bupivacaine, the
other group receives no extra treatment besides optimal medical treatment.
Study burden and risks
Agenda
* At inclusion: NRS 4 days 3 times a day, QLC-30, PAN-28, MQS, PD/M, EuroQol-5D
(EQ-5D), BDI
* The intervention: PRFLSN or no intervention
* 1 week after intervention NRS 4 days 3 times a day, GPE, QLC-30, PAN-28, MQS,
* 1 month after intervention NRS 4 days 3 times a day, GPE, QLC-30, PAN-28,
MQS, EQ-5D, BDI
* 2 months after intervention NRS 4 days 3 times a day, GPE, QLC-30, PAN-28, MQS
* 3 months after intervention NRS 4 days 3 times a day, GPE, QLC-30, PAN-28,
MQS, PD/M, EQ-5D, BDI
Risks of PRFLSN
RF lesioning has a definite advantage over phenol and alcohol neurolytic
techniques because the RF lesioning is circumscribed and controlled. The
proximal and distal spread of the lesion beyond the uninsulated tip of the
probe is only 1 mm and the cross sectional diameter of the lesion is 5-6 mm.
There is no possibility of nerve root damage or destructive damage of epidural
and subarachnoid structures assuming that electrode placement can be verified
by fluoroscopy and pretesting with electrical stimulation and impedance
monitoring.
Numbness or motor paralysis occurs very rarely as a consequence of the
lesioning. The tissues can be injured anywhere along the needle if there is a
break in the insulation. Therefore, sensory and motor stimulation is always a
prerequisite for such lesioning.
Pneumothorax and diarrhoea can occur following splanchnic nerve blocks. In a
study by Raj et al. 31 patients underwent PRFLSN after a trial block with a
local anaesthetic. There were no complications.
Debeyelaan 25
6202 AZ Maastricht
NL
Debeyelaan 25
6202 AZ Maastricht
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 0911111 |
CCMO | NL29137.068.09 |