Clinical trial NCT04801082: Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain
Official title: Endoscopic Ultrasound-Guided Coeliac Plexus Neurolysis for Cancer Pain: Chemical Versus Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
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
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of pain score
timeFrame: 4 weeks after the procedure
Secondary outcomes:
measure: Change of pain score
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Analgesic requirement
timeFrame: Up to 100 months (From the date of procedure until the date of death from any cause)
measure: Technical success rate
timeFrame: 1 day
measure: Clinical success rate
timeFrame: Through study completion, an average of 2 year
measure: Duration of procedure
timeFrame: Up to 1 hour
measure: Time to pain score drop by 50%
timeFrame: Through study completion, an average of 2 year
measure: Short term complication rate
timeFrame: Up to 1 week
measure: Long term complication rate
timeFrame: Through study completion, an average of 2 year
measure: Hospital length of stay
timeFrame: Up to 100 months
measure: Health status (Quality of life)
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Quality of life (QOL) in patients with pancreatic cancer
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Quality of life (QOL) of cancer patients
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Cost-effectiveness
timeFrame: Through study completion, an average of 2 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ka Wing Ma, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References: