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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02220062
Enrollment
166
Registered
2014-08-19
Start date
2014-08-31
Completion date
Unknown
Last updated
2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Brief summary

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.

Interventions

PROCEDUREEUS-CPN

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.

PROCEDUREEUS-CGN

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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. At least 19 years old age (above 70 years old age, need the consent of the legal representative) 2. Inoperable pancreatic cancer patients 3. Pancreatic cancer patients with inadequate pain control by pain killer (VAS score 4 points or more) 4. Patient who agree to participate in this study

Exclusion criteria

1. Abnormal clotting (international normalized ratio ≥1.5) 2. Reduced platelet count (≤50000/μL) 3. Use of anticoagulation agents 4. Presence of gastric and/or esophageal varices 5. Anatomical deformity due to past surgery

Design outcomes

Primary

MeasureTime frame
percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)1 week after procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026