Randomized, Controlled Trial of Endoscopic Ultrasound-Guided Bilateral Celiac Plexus Neurolysis vs Celiac Ganglia Neurolysis to Control Pain in Inoperable Pancreatic Cancer Patients With Inadequate Pain Control by Pain Killer

Study Overview
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Brief Summary
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Pancreatic cancer related pain can be difficult to control, even with high doses of narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic ultrasound guided celiac plexus neurolysis) is well established as an effective technique for controlling pain and reducing narcotic requirements in patients with pancreatic cancer. Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it allows for direct injection into individual celiac ganglia to perform celiac ganglia neurolysis. This more precise delivery of therapeutic drug will offers the potential for enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus neurolysis) in providing relief from pancreas cancer-related pain.

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Procedure: EUS-CPN
* Procedure: EUS-CGN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 19 years old age (above 70 years old age, need the consent of the legal representative) Inoperable pancreatic cancer patients Pancreatic cancer patients with inadequate pain control by pain killer (VAS score 4 points or more) Patient who agree to participate in this study Exclusion Criteria: Abnormal clotting (international normalized ratio ≥1.5) Reduced platelet count (≤50000/μL) Use of anticoagulation agents Presence of gastric and/or esophageal varices Anatomical deformity due to past surgery

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-CPN group<br>Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis | Procedure: EUS-CPN<br>* After initially identifying the celiac trunk on endoscopic ultrasound, each injection of 5 10cc ethanol would be performed as bilateral injections at the celiac trunk.<br>|
| Experimental: EUS-CGN group<br>Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis | Procedure: EUS-CGN<br>* First, identify celiac ganglia. If the celiac ganglia are visualized under linear EUS, the injection of 2 3cc ethanol are applied directly into the each ganglia. If the ganglia are not identified by EUS, bilateral EUS-CPN would be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS) |  | 1 week after procedure |