Chronic Pancreatitis, Pancreatic Cancer
Conditions
Brief summary
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.
Interventions
OTHERone injection into the celiac ganglion
one injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
OTHERtwo injections into the celiac ganglion
two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed