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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

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ClinicalTrials.gov Identifier: NCT02220062
Recruitment Status : Unknown
Verified August 2014 by Jong Kyun Lee, Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Jong Kyun Lee, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Procedure: EUS-CPN Procedure: EUS-CGN Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2014
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EUS-CPN group
Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis
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.

Experimental: EUS-CGN group
Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis
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




Primary Outcome Measures :
  1. percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS) [ Time Frame: 1 week after procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Jong Kyun Lee, Professor, Department of Gastroenterology, Sungkyunkwan University School of Medicine, Samsung Medical center, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02220062    
Other Study ID Numbers: 2014-02-088-005
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases