NCT04809935

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

Endoscopic Ultrasound Guided Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Intractable Pain Due to Malignancy A Randomized Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of Pancreas
• Pancreatic Neoplasms
• Pain
• Cancer-Associated Pain
• Pain Management

Interventions

Type	Name	Description
DRUG	98% dehydrated alcohol	* coeliac plexus is identified and punctured * Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol.
DEVICE	19G 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

Timeline

• Start date: 2020-09-21
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2021-03-22
• Last updated: 2021-03-22

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study
• FDA-regulated device study