Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

Study Overview
=================
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.

Official Title
-----------------
Endoscopic Ultrasound-Guided Coeliac Plexus Neurolysis for Cancer Pain: Chemical Versus Radiofrequency Ablation

Conditions
-----------------
Malignancy, Pain Management

Intervention / Treatment
-----------------
* Drug: Alcohol injection
* Device: Radiofrequency Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-CPB<br>Endoscopic Ultrasound Guided Coeliac Plexus Block | Drug: Alcohol injection<br>* 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)<br>* Other names: Chemical Ablation;|
| Active Comparator: EUS-CPA<br>Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation | Device: Radiofrequency Ablation<br>* 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.<br>* Other names: RFA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain score | change of pain score at 4th week after the procedure (by VAS score) | 4 weeks after the procedure | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Intra-abdominal malignancy, Pain Relief, Chemical coeliac plexus neurolysis, Coeliac plexus ablation, Cancer pain