Prospective Study of Celiac Block Injection: 1 vs. 2

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study of Celiac Block Technique: One Injection or Two?

Conditions
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Chronic Pancreatitis, Pancreatic Cancer

Intervention / Treatment
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* Other: one injection into the celiac ganglion
* Other: two injections into the celiac ganglion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>subjects who get one medication injection into the celiac ganglion during the EUS | Other: one injection into the celiac ganglion<br>* one injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer<br>|
| Other: B<br>subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS | Other: two injections into the celiac ganglion<br>* two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region |  | 24-hour after the procedure; then every week thereafter until the subject is no longer in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in medication use |  | at 24-hours after procedure and every week thereafter until the subject is no longer in the study | 
| change is pain score |  | at 24-hours after procedure and every week thereafter until the subject is no longer in the study | 
| complications related to CB |  | at 24-hours after procedure and every week thereafter until the subject is no longer in the study |