Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

NCT04801082 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: 202009185043
• 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

Malignancy; Pain Management

Keywords

Endoscopic Ultrasound Guided; Radiofrequency Ablation; Coeliac plexus neurolysis; Intra-abdominal malignancy; Pain Relief; Chemical coeliac plexus neurolysis; Coeliac plexus ablation; Cancer pain

Outcome Measures

Primary Outcomes (1)

• Change of pain score

  change of pain score at 4th week after the procedure (by VAS score)

  4 weeks after the procedure

Secondary Outcomes (13)

• Change of pain score

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

• Analgesic requirement

  Up to 100 months (From the date of procedure until the date of death from any cause)

• Technical success rate

  1 day

• Clinical success rate

  Through study completion, an average of 2 year

• Duration of procedure

  Up to 1 hour

Study Arms (2)

EUS-CPB

ACTIVE COMPARATOR

Endoscopic Ultrasound Guided Coeliac Plexus Block

Drug: Alcohol injection

EUS-CPA

ACTIVE COMPARATOR

Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation

Device: Radiofrequency Ablation

Interventions

Alcohol injection 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)

Also known as: Chemical Ablation

EUS-CPB

Radiofrequency Ablation 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.

Also known as: RFA

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, biliary system and liver (both primary or secondary)

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)

The University of Hong Kong

Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms; Agnosia; Cancer Pain

Interventions

Ethanol; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

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

Ka Wing Ma, MBBS, MS

CONTACT

+852 2255 3025; kawingma@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 8, 2021
• First Posted: March 16, 2021
• Study Start: March 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: March 31, 2025
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

HK (1)