Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

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

2021-03-31

Study Completion Date

2025-03-31

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.

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Detailed Description

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The aim of this study is to compare the efficacy of EUS-CPN by chemical ablation using alcohol injection versus by radiofrequency ablation in patients with cancer pain related to intra-abdominal malignancy. This is a randomised controlled trial to assess the clinical outcomes and cost-effectiveness of this new treatment approach.

Conditions

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Malignancy 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

Endoscopic Ultrasound Guided Coeliac Plexus Block

Group Type ACTIVE_COMPARATOR

Alcohol injection

Intervention Type DRUG

Chemical ablation is performed by injection of 10 mL of 0.25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol using a 22G FNA needle (Cook and Olympus)

EUS-CPA

Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation

Group Type ACTIVE_COMPARATOR

Radiofrequency Ablation

Intervention Type DEVICE

coeliac plexus is identified and punctured with 19G EUSRA RFA needle with 10W-30W of energy for 10-50s bilaterally or unilaterally depends on individual anatomical characteristics.

Interventions

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Alcohol injection

Chemical ablation is performed by injection of 10 mL of 0.25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol using a 22G FNA needle (Cook and Olympus)

Intervention Type DRUG

Radiofrequency Ablation

coeliac plexus is identified and punctured with 19G EUSRA RFA needle with 10W-30W of energy for 10-50s bilaterally or unilaterally depends on individual anatomical characteristics.

Intervention Type DEVICE

Other Intervention Names

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Chemical Ablation RFA

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, biliary system and liver (both primary or secondary)

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