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

The University of Hong Kong (HKU)

Status and phase: Unknown; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04809935

204610401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

EUS-CPB

Active Comparator group

Description:

Chemical ablation of the coeliac plexus

Treatment:

Drug: 98% dehydrated alcohol

EUS-CPA

Active Comparator group

Description:

Radiofrequency ablation of the coeliac plexus

Treatment:

Device: 19G EUSRA needle, Taewoong Medical, Korea