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

March 17, 2021 updated by: Dr. Ma Ka Wing, The University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wan Yee Chiu, BISC
  • Phone Number: +852 2255 4848
  • Email: krissy23@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • Recruiting
        • Queen Mary Hospital
        • Contact:
        • Principal Investigator:
          • Ka Wing Ma, MBBS, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EUS-CPB
Chemical ablation of the coeliac plexus
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.
Other Names:
  • Chemical Ablation
Active Comparator: EUS-CPA
Radiofrequency ablation of the coeliac plexus
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 4 weeks
Pain score at 4 weeks after procedure (by VAS score)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to pain score drop by 50%
Time Frame: Through study completion, an average of 2 year
Time to Visual Analog Score drop by 50%
Through study completion, an average of 2 year
Hospital length of stay
Time Frame: Up to 100 months
Hospital length of stay
Up to 100 months
Health status (Quality of life)
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
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
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
PAN-26 questionnaire
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) of cancer patients
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
QLQ-C30 questionnaire
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Technical success rate
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Technical success rate
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Clinical success rate
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Decrease of pain level by 30% from pre-procedural baseline
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Duration of procedure
Time Frame: Up to 1 hour
Time from injection of pre-medication to procedure last observation recording at the procedure suite
Up to 1 hour
Short term complication rate
Time Frame: Up to 1 week
Complication rate
Up to 1 week
Long term complication rate
Time Frame: Through study completion, an average of 2 year
Complication rate
Through study completion, an average of 2 year
Cost-effectiveness of two types approach
Time Frame: Through study completion, an average of 2 year
Total cost ($) of treatment
Through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Ka Wing Ma, MBBS, MS, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 204610401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on 98% dehydrated alcohol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe