Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

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Pancreatic Neoplasms

Cancer Pain

Pain

Celiac Disease

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Biliary Tract Cancer

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Anti-Infective Agents, Local

Celiac plexus neurolysis by alcohol injection One time administration during surgery 20 ml of alcohol injection on each side of aorta at level of celiac axis

Celiac plexus injection - placebo injection

Celiac plexus neurolysis by alcohol injection

Alcohol Injection

Placebo Injection

Michael G House, MD

This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.

Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer.

Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.

Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control

A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies

Indiana University

Associate Professor of Surgery

Nervous System Diseases

Neurologic Manifestations

Bupivacaine

Endoscopic Ultrasound Guided Coeliac Plexus Block

Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation

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)

Alcohol injection

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.

Radiofrequency Ablation

Wan Yee Chiu, BISC

Ka Wing Ma, MBBS, MS

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.

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.

Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

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

change of pain score at 4th week after the procedure (by VAS score)

change of pain score (Visual Analog Score) after the procedure

decrease in pain level by 30% from the pre-procedural baseline

time from injection of pre-medication to procedure last observation recording at the procedure suite

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control	NCT02002806	Pancreas Cancer Biliary Tract C...	Alcohol Injecti... Placebo Injecti...	18 Years - 85 Years	Indiana University
Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain	NCT04801082	Malignancy Pain Management	Alcohol injecti... Radiofrequency ...	18 Years -	The University of Hong Kong
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control	NCT02002806	Pancreas Cancer Biliary Tract C...	Alcohol Injecti... Placebo Injecti...	18 Years - 85 Years	Indiana University

Spots Global Cancer Trial Database for alcohol injection