Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

Endoscopic Ultrasound-Guided Coeliac Plexus Neurolysis for Cancer Pain: Chemical Versus Radiofrequency Ablation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management; Malignancy
• Intervention / Treatment: Drug: Alcohol injection; Device: Radiofrequency Ablation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wan Yee Chiu, BISC; Phone Number: +852 2255 4848; Email: krissy23@hku.hk
• Study Contact Backup: Name: Ka Wing Ma, MBBS, MS; Phone Number: +852 2255 3025; Email: kawingma@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • The University of Hong Kong
    • Contact: Ka Wing Ma, MBBS, MS; Phone Number: +852 2255 3025; Email: kawingma@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EUS-CPB; Endoscopic Ultrasound Guided Coeliac Plexus Block	Drug: 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); Other Names: Chemical Ablation
Active Comparator: EUS-CPA; Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation	Device: 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.; Other Names: RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of pain score	change of pain score at 4th week after the procedure (by VAS score)	4 weeks after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of pain score	change of pain score (Visual Analog Score) after the procedure	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Analgesic requirement	decrease in analgesic requirement	Up to 100 months (From the date of procedure until the date of death from any cause)
Technical success rate	technical success rate	1 day
Clinical success rate	decrease in pain level by 30% from the pre-procedural baseline	Through study completion, an average of 2 year
Duration of procedure	time from injection of pre-medication to procedure last observation recording at the procedure suite	Up to 1 hour
Time to pain score drop by 50%	Time to Visual Analog Score drop by 50%	Through study completion, an average of 2 year
Short term complication rate	complication rate	Up to 1 week
Long term complication rate	complication rate	Through study completion, an average of 2 year
Hospital length of stay	Hospital length of stay	Up to 100 months
Health status (Quality of life)	The Short Form (36) Health Survey	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) in patients with pancreatic cancer	PAN-26 questionnaire	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Quality of life (QOL) of cancer patients	QLQ-C30 questionnaire	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Cost-effectiveness	Total cost ($) of the treatment	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Ka Wing Ma, MBBS, MS, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; Cancer pain; Pain Relief; Endoscopic Ultrasound Guided; Coeliac plexus neurolysis; Intra-abdominal malignancy; Chemical coeliac plexus neurolysis; Coeliac plexus ablation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neoplasms; Cancer Pain
• Other Study ID Numbers: 202009185043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes