Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

Phase 4

Not yet recruiting

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Age ≥18 year-old
Patients who give informed consent to the study
Suboptimal pain control with regular analgesics
Inoperable cancer of pancreas, biliary system and liver (both primary or secondary)

Exclusion Criteria

Patients who refuse to give consent
Patients aged <18 years
EUS not possible due to:
Problem related to scope insertion such as trismus, stenosis of the upper GI tract
Coagulopathy with INR >1.5 or platelet count < 70
Low oxygen saturation or extreme blood pressure render endoscopic procedure unsafe

Arm && Interventions

Group	Intervention	Description
EUS-CPB	Alcohol injection	Endoscopic Ultrasound Guided Coeliac Plexus Block
EUS-CPA	Radiofrequency Ablation	Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation

Primary Outcome Measures

Name	Time	Method
Change of pain score	4 weeks after the procedure	change of pain score at 4th week after the procedure (by VAS score)

Secondary Outcome Measures

Name	Time	Method
Short term complication rate	Up to 1 week	complication rate
Analgesic requirement	Up to 100 months (From the date of procedure until the date of death from any cause)	decrease in analgesic requirement
Duration of procedure	Up to 1 hour	time from injection of pre-medication to procedure last observation recording at the procedure suite
Change of pain score	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks	change of pain score (Visual Analog Score) after the procedure
Technical success rate	1 day	technical success rate
Time to pain score drop by 50%	Through study completion, an average of 2 year	Time to Visual Analog Score drop by 50%
Long term complication rate	Through study completion, an average of 2 year	complication rate
Hospital length of stay	Up to 100 months	Hospital length of stay
Health status (Quality of life)	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks	The Short Form (36) Health Survey
Quality of life (QOL) of cancer patients	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks	QLQ-C30 questionnaire
Clinical success rate	Through study completion, an average of 2 year	decrease in pain level by 30% from the pre-procedural baseline
Quality of life (QOL) in patients with pancreatic cancer	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks	PAN-26 questionnaire
Cost-effectiveness	Through study completion, an average of 2 year	Total cost ($) of the treatment