EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy

Phase 4

Conditions: Pancreatic Neoplasms
Pain
Cancer of Pancreas
Pain Management
Cancer-Associated Pain

Interventions: Device: 19G EUSRA needle, Taewoong Medical, Korea
Drug: 98% dehydrated alcohol

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-guided CPN versus radiofrequency ablation in patients with pain related to pancreatic cancer. By performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new RFA treatment approach can be evaluated.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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-CPA	19G EUSRA needle, Taewoong Medical, Korea	Radiofrequency ablation of the coeliac plexus
EUS-CPB	98% dehydrated alcohol	Chemical ablation of the coeliac plexus

Primary Outcome Measures

Name	Time	Method
Pain score	4 weeks	Pain score at 4 weeks after procedure (by VAS score)

Secondary Outcome Measures

Name	Time	Method
Technical success rate	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks	Technical success rate
Clinical success rate	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks	Decrease of pain level by 30% from 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
Quality of life (QOL) of cancer patients	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks	QLQ-C30 questionnaire
Cost-effectiveness of two types approach	Through study completion, an average of 2 year	Total cost ($) of treatment
Health status (Quality of life)	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks	The Short Form (36) Health Survey
Time to pain score drop by 50%	Through study completion, an average of 2 year	Time to Visual Analog Score drop by 50%
Short term complication rate	Up to 1 week	Complication rate
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
Duration of procedure	Up to 1 hour	Time from injection of pre-medication to procedure last observation recording at the procedure suite