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 | Unknown

• 1 other identifier: 2014-02-088-005
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)

  1 week after procedure

Study Arms (2)

EUS-CPN group

ACTIVE COMPARATOR

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

Procedure: EUS-CPN

EUS-CGN group

EXPERIMENTAL

Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis

Procedure: EUS-CGN

Interventions

EUS-CPN PROCEDURE

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.

EUS-CPN group

EUS-CGN PROCEDURE

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

EUS-CGN group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Gastroenterology, Sungkyunkwan University School of Medicine, Samsung Medical center

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: August 19, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Last Updated: August 19, 2014

Record last verified: 2014-08