Intractable Abdominal Pain Secondary to Inoperable Malignancy Clinical Trial
Official title:
A Randomized Controlled Trial on Endoscopic Ultrasound-guided Celiac Ganglion Neurolysis Versus Percutaneous Celiac Plexus Neurolysis in Patients With Inoperable Cancer
Patients suffering from pancreatic cancer are associated with a poor prognosis and survival
of less than one year is expected in inoperable tumours. Management of these patients would
be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this
"intractable" pain is often difficult to treat. Different pharmacological agents have been
used in the past to control this pain and these include non-steroidal anti-inflammatory drugs
and narcotic agents. However, patients' responses are often variable and difficult to
predict. Furthermore, these agents are associated with their own adverse effects and may
further impair quality of life.
Celiac plexus neurolysis (CPN) was first described in 1919, since then, different approaches
of performing the procedure have been described. The standard technique involves a
percutaneous approach but CPN can also be performed by an intra-operative approach with open
or laparoscopic means. Results from meta-analysis have shown that CPN was associated with
superior pain relief as compared to analgesic therapy alone and reduces the need for opioids
analgesics in patients with inoperable pancreatic cancer. Furthermore, CPN causes fewer
adverse effects than opioid analgesics and it is the preferred method of improving pain
relief in these patients.
Recently, endoscopic ultrasonography (EUS) - guided CPN has become popular. The approach is
safe and effective and was shown to be associated with long lasting pain relieve in patients
suffering from chronic pancreatitis or pancreatic cancer. Serious complications are uncommon
and are less than 2% in these series. Transient diarrhoea and hypotension are common after
CPN and is seen up to 30% to 40% of the patients, regardless of whether the procedure is
being done by the EUS or percutaneous approach. The EUS approach offers several theoretical
advantages over the percutaneous option. Most notably is the visualization of the celiac
ganglia situated anterior to the aorta, allowing direct injection of the ganglia with alcohol
resulting in celiac ganglion neurolysis (CGN). This increases the accuracy of CPN and may
result in improved pain control. Furthermore, it could reduce complications associated with
the percutaneous approach that includes lower extremity paresthesia and paralysis.
Hence, the aim of the study is to compare the efficacy and safety of endoscopic ultrasound
(EUS)-guided celiac ganglion neurolysis (CGN) versus percutaneous celiac plexus neurolysis
(CPN) in reducing cancer pain in patients suffering from inoperable cancer. With direct
visualization and injection of the celiac ganglion, the investigators hypothesis that
EUS-guided CGN is more advantageous on improving pain relief and decreasing the need for
opioid analgesics in patients with inoperable cancer as compared to percutaneous CPN.
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