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

Samsung Medical Center

Status: Unknown

Conditions: Pancreatic Neoplasms

Treatments: Procedure: EUS-CGN; Procedure: EUS-CPN

Study type: Interventional

Funder types: Other

Identifiers

NCT02220062

2014-02-088-005

Details and patient eligibility

About

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.

Enrollment: 166 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

EUS-CPN group

Active Comparator group

Description:

Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis

Treatment:

Procedure: EUS-CPN

EUS-CGN group

Experimental group

Description:

Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis

Treatment:

Procedure: EUS-CGN