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

Not Applicable

• Conditions: Pancreatic Neoplasms
• Interventions: Procedure: EUS-CPN; Procedure: EUS-CGN

• Registration Number: NCT02220062
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-07-21
• Status Verified: 2014-08
• Study Start: 2014-08
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-19
• Last Update Posted: 2014-08-19
• Primary Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS-CPN group	EUS-CPN	Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis
EUS-CGN group	EUS-CGN	Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis

Primary Outcome Measures

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