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
NCT02220062 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166
Last updated 2014-08-19
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.
Conditions
- Pancreatic Neoplasms
Interventions
- PROCEDURE
-
EUS-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.
- PROCEDURE
-
EUS-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 & Collaborators
-
Samsung Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2016-08-31
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