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

NCT04809935 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-03-22

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Ka Wing Ma, MBBS, MS · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809935 on ClinicalTrials.gov