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

NCT04809935 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: 204610401
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endoscopic Ultrasound Guided; Radiofrequency Ablation; Coeliac plexus neurolysis; Pancreatic cancer; Pain Relief; Chemical coeliac plexus neurolysis; Coeliac plexus ablation; Cancer pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain score at 4 weeks after procedure (by VAS score)

  4 weeks

Secondary Outcomes (11)

• Technical success rate

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks

• Clinical success rate

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks

• Duration of procedure

  Up to 1 hour

• Time to pain score drop by 50%

  Through study completion, an average of 2 year

• Short term complication rate

  Up to 1 week

Study Arms (2)

EUS-CPB

ACTIVE COMPARATOR

Chemical ablation of the coeliac plexus

Drug: 98% dehydrated alcohol

EUS-CPA

ACTIVE COMPARATOR

Radiofrequency ablation of the coeliac plexus

Device: 19G EUSRA needle, Taewoong Medical, Korea

Interventions

98% dehydrated alcohol DRUG

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

Also known as: Chemical Ablation

EUS-CPB

19G EUSRA needle, Taewoong Medical, Korea 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

EUS-CPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 year-old
• Patients who give informed consent to the study
• Suboptimal pain control with regular analgesics
• Inoperable cancer of pancreas

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Pain; Cancer Pain; Agnosia

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Ka Wing Ma, MBBS, MS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan Yee Chiu, BISC

CONTACT

+852 2255 4848; krissy23@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 22, 2021
• Study Start: September 21, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

HK (1)