Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection. Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.
The aim of this study is to compare the efficacy of EUS-CPN by chemical ablation using alcohol injection versus by radiofrequency ablation in patients with cancer pain related to intra-abdominal malignancy. This is a randomised controlled trial to assess the clinical outcomes and cost-effectiveness of this new treatment approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Chemical ablation is performed by injection of 10 mL of 0.25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol using a 22G FNA needle (Cook and Olympus)
coeliac plexus is identified and punctured with 19G EUSRA RFA needle with 10W-30W of energy for 10-50s bilaterally or unilaterally depends on individual anatomical characteristics.
The University of Hong Kong
Hong Kong, Hong Kong
Change of pain score
change of pain score at 4th week after the procedure (by VAS score)
Time frame: 4 weeks after the procedure
Change of pain score
change of pain score (Visual Analog Score) after the procedure
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Analgesic requirement
decrease in analgesic requirement
Time frame: Up to 100 months (From the date of procedure until the date of death from any cause)
Technical success rate
technical success rate
Time frame: 1 day
Clinical success rate
decrease in pain level by 30% from the pre-procedural baseline
Time frame: Through study completion, an average of 2 year
Duration of procedure
time from injection of pre-medication to procedure last observation recording at the procedure suite
Time frame: Up to 1 hour
Time to pain score drop by 50%
Time to Visual Analog Score drop by 50%
Time frame: Through study completion, an average of 2 year
Short term complication rate
complication rate
Time frame: Up to 1 week
Long term complication rate
complication rate
Time frame: Through study completion, an average of 2 year
Hospital length of stay
Hospital length of stay
Time frame: Up to 100 months
Health status (Quality of life)
The Short Form (36) Health Survey
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) in patients with pancreatic cancer
PAN-26 questionnaire
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) of cancer patients
QLQ-C30 questionnaire
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Cost-effectiveness
Total cost ($) of the treatment
Time frame: Through study completion, an average of 2 year
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