Patients with unresectable pancreatic cancer are often demoralized by intractable, persistent and incapacitating pain. It must be managed aggressively and strong opioids are recommended as the mainstay of treatment. However, patients develop opioid-related adverse effects. EUS-guided celiac plexus neurolysis (CPN) and celiac ganglion neurolysis (CGN) has been shown to provide high efficacy for pain control. The optimal timing, however, is in debate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
The EUS scope was first inserted into the stomach, and the coeliac trunk was visualized by scanning from the lesser curve of the gastric body. After visualization, the scope was rotated clockwise, enabling visualization and identification of the left adrenal gland. The coeliac ganglia are often seen to the left of the coeliac artery, between the aorta and the left adrenal gland, at the level between the coeliac artery and the left adrenal artery. They are also visualized cephalad to the coeliac artery in some cases. Hypoechoic nodular structures linked by hypoechoic threads residing in the periphery of this region were defined as the coeliac ganglia . A 19G or 22G needle was used for puncture of the CGN. After confirming the lack of backflow of blood with aspiration, a mixture of 5ml of 0.25-0.5% bupivacaine and 5ml absolute alcohol was injected. For cases in which celiac ganglia could not be visualized, EUS-guided coeliac plexus neurolysis (CPN) will be performed.
Prince of Wales Hospital
Hong Kong, Hong Kong
RECRUITINGThe mean change in VAS pain score at 3 months
The mean change in VAS pain score at 3 months when compared to baseline (pre-procedure) between upfront EUS group and conventional step-up group
Time frame: 3 months
The mean percentage and absolute change in VAS pain score at 1 month
The mean percentage and absolute change in VAS pain score at 1 month when compared to baseline (pre-procedure)
Time frame: 1 month
The mean percentage in VAS pain score at 3 month
The mean percentage in VAS pain score at 3 month when compared to baseline (pre-procedure)
Time frame: 3 months
Short form McGill Pain Questionnaire-2
The absolute and mean percentage change in Short form McGill Pain Questionnaire-2
Time frame: 3 months
Brief Pain Inventory
The absolute and mean percentage change in Brief Pain Inventory
Time frame: 3 months
Morphine equivalent (MEQ) consumption
Absolute use and percentage change of morphine (expressed in morphine equivalent (MEQ) consumption) when compared to baseline
Time frame: 3 months
Common opioid-related adverse effects
Common opioid-related adverse effects including nausea, pruritus, constipation and drowsiness will be recorded
Time frame: 3 months
Quality of life
Changes of the score in quality of life (EORTC QLQ-C30)
Time frame: 3 months
Karnofsky performance status
Karnofsky performance status at baseline, 4 weeks, 8 weeks and 12 weeks
Time frame: 12 weeks
Adverse events from the EUS-guided CGN/CPN
Adverse events from the EUS-guided CGN/CPN will be recorded
Time frame: 7 days
Breakthrough visits
Breakthrough visits in between the 4 weeks
Time frame: 4 weeks
Need for and timing EUS-guided CGN/CPN for the conventional group
Need for and timing EUS-guided CGN/CPN for the conventional group will be recorded
Time frame: 3months
Overall survival
Date of death will be recorded
Time frame: 48 weeks
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