Back to resultsRandomized, 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
Primary Purpose
Pancreatic Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EUS-CPN
EUS-CGN
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EUS-CPN group
EUS-CGN group
Arm Description
Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis
Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis
Outcomes
Primary Outcome Measures
percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02220062
Brief Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-CPN group
Arm Type
Active Comparator
Arm Description
Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis
Arm Title
EUS-CGN group
Arm Type
Experimental
Arm Description
Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis
Intervention Type
Procedure
Intervention Name(s)
EUS-CPN
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
EUS-CGN
Intervention Description
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
Primary Outcome Measure Information:
Title
percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)
Time Frame
1 week after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
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
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