Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04801082
• Other study ID #: 202009185043
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2021
• Source: The University of Hong Kong
• Contact: Wan Yee Chiu, BISC
• Phone: +852 2255 4848
• Email: krissy23[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: March 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Malignancy
• Neoplasms
• Pain Management

Intervention

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)

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.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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