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

NCT ID: NCT02220062

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EUS-CPN group

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

Group Type: ACTIVE_COMPARATOR

EUS-CPN

Intervention Type: 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-CGN group

Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis

Group Type: EXPERIMENTAL

EUS-CGN

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jong Kyun Lee

Professor, Department of Gastroenterology, Sungkyunkwan University School of Medicine, Samsung Medical center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2014-02-088-005

Identifier Type: -

Identifier Source: org_study_id