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

NCT ID: NCT04809935

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2024-01-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EUS-CPB

Chemical ablation of the coeliac plexus

Group Type ACTIVE_COMPARATOR

98% dehydrated alcohol

Intervention Type DRUG

* coeliac plexus is identified and punctured
* Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol.

EUS-CPA

Radiofrequency ablation of the coeliac plexus

Group Type ACTIVE_COMPARATOR

19G EUSRA needle, Taewoong Medical, Korea

Intervention Type DEVICE

* 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

Interventions

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98% dehydrated alcohol

* coeliac plexus is identified and punctured
* Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol.

Intervention Type DRUG

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

Intervention Type DEVICE

Other Intervention Names

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Chemical Ablation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ma Ka Wing

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ka Wing Ma, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Wan Yee Chiu, BISC

Role: CONTACT

+852 2255 4848

Facility Contacts

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Wan Yee Chiu, BISC

Role: primary

+852 2255 4848

Other Identifiers

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204610401

Identifier Type: -

Identifier Source: org_study_id

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