EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy
NCT ID: NCT04809935
Last Updated: 2021-03-22
Study Results
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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UNKNOWN
PHASE4
54 participants
INTERVENTIONAL
2020-09-21
2024-01-31
Brief Summary
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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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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EUS-CPB
Chemical ablation of the coeliac plexus
98% dehydrated alcohol
* 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
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
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who give informed consent to the study
* Suboptimal pain control with regular analgesics
* Inoperable cancer of pancreas
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Ma Ka Wing
Clinical Assistant Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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204610401
Identifier Type: -
Identifier Source: org_study_id
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