Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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-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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-CPB | Active Comparator | Chemical ablation of the coeliac plexus |
|
| EUS-CPA | Active Comparator | Radiofrequency ablation of the coeliac plexus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 98% dehydrated alcohol | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain score at 4 weeks after procedure (by VAS score) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Technical success rate | 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
| Clinical success rate | Decrease of pain level by 30% from pre-procedural baseline |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan Yee Chiu, BISC | Contact | +852 2255 4848 | krissy23@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Ka Wing Ma, MBBS, MS | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | 000000 | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 19G EUSRA needle, Taewoong Medical, Korea | Device |
|
|
| 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
| 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 of two types approach | Total cost ($) of treatment | Through study completion, an average of 2 year |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010146 | Pain |
| D000072716 | Cancer Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided