Cancer-Associated Pain, Cancer of Pancreas, Pain, Pain Management, Pancreatic Neoplasms
Conditions
Keywords
Endoscopic Ultrasound Guided, Radiofrequency Ablation, Coeliac plexus neurolysis, Pancreatic cancer, Pain Relief, Chemical coeliac plexus neurolysis, Coeliac plexus ablation, Cancer pain
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.
Interventions
DEVICE19G EUSRA needle, Taewoong Medical, Korea
* 10W-30W RFA will be applied unilaterally or bilaterally depends on individual anatomical characteristics for 10-50s * Complete ablation of coeliac plexus nervous tissue is confirmed by appearance of air-bubble ultrasound scan
* coeliac plexus is identified and punctured * Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 year-old * Patients who give informed consent to the study * Suboptimal pain control with regular analgesics * Inoperable cancer of pancreas
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 4 weeks | Pain score at 4 weeks after procedure (by VAS score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate | 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks | Decrease of pain level by 30% from pre-procedural baseline |
| Duration of procedure | Up to 1 hour | Time from injection of pre-medication to procedure last observation recording at the procedure suite |
| 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 |
| Technical success rate | 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks | Technical success rate |
| 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) 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 |
| Hospital length of stay | Up to 100 months | Hospital length of stay |
Countries
Hong Kong
Contacts
Primary ContactWan Yee Chiu, BISC
Outcome results
None listed