Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

The University of Hong Kong (HKU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Pain Management; Malignancy

Treatments: Drug: Alcohol injection; Device: Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04801082

202009185043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

EUS-CPB

Active Comparator group

Description:

Endoscopic Ultrasound Guided Coeliac Plexus Block

Treatment:

Drug: Alcohol injection

EUS-CPA

Active Comparator group

Description:

Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation

Treatment:

Device: Radiofrequency Ablation