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

Pain Clinical Trial

Official title:

Endoscopic Ultrasound Guided Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Intractable Pain Due to Malignancy A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809935
• Other study ID #: 204610401
• Status: Recruiting
• Phase: Phase 4
• Start date: September 21, 2020
• Est. completion date: January 31, 2024

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-guided CPN versus radiofrequency ablation in patients with pain related to pancreatic cancer. By performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new RFA treatment approach can be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: January 31, 2024
• 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

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 of Pancreas
• Cancer Pain
• Cancer-Associated Pain
• Pain
• Pain Management
• Pancreatic Neoplasms

Intervention

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

Device:
• 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

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	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	Pain score	Pain score at 4 weeks after procedure (by VAS score)	4 weeks
Secondary	Technical success rate	Technical success rate	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary	Clinical success rate	Decrease of pain level by 30% from pre-procedural baseline	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
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 of two types approach	Total cost ($) of treatment	Through study completion, an average of 2 year