Prospective Study of Celiac Block Injection: 1 vs. 2

Indiana University

Status and phase: Completed; Phase 4

Conditions: Chronic Pancreatitis; Pancreatic Cancer

Treatments: Other: one injection into the celiac ganglion; Other: two injections into the celiac ganglion

Study type: Interventional

Funder types: Other

Identifiers

NCT00583479

0203-32

Details and patient eligibility

About

The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block will be eligible to participate in this study. Chronic pancreatitis and pancreatic cancer must be measured and documented by prior CT, ERCP, or EUS.
• Patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit survivability of the sedation given or the procedure.
• Age > or = to 18 years
• No evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc)
• No evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc)
• No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
• Patient must provide signed written informed consent.
• Patients that have had a previous celiac plexus block are eligible for this study

Exclusion criteria

• The patient's celiac trunk should be imaged clearly under endoscopic ultrasound. The patient's celiac plexus should be accessed easily with a needle for the medication injection. If this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

A

Other group

Description:

subjects who get one medication injection into the celiac ganglion during the EUS

Treatment:

Other: one injection into the celiac ganglion

B

Other group

Description:

subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS

Treatment:

Other: two injections into the celiac ganglion