The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.
Chronic pancreatitis is a complex fibroinflammatory disease arising from numerous etiological factors and a variety of clinical manifestations. Abdominal pain is the most debilitating complication and can result in significant morbidity and impact on quality of life. Endoscopic ultrasonography (EUS) has been increasingly utilized for celiac plexus block (EUS-CPB), whereby a steroid in combination with a local anesthetic agent are injected into the celiac plexus within the abdominal cavity. The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.
Celiac plexus will not be performed in this arm.
Orlando Health
Orlando, Florida, United States
RECRUITINGRate of adequate pain relief
Rate of adequate pain relief in patients with chronic pancreatitis undergoing endoscopic ultrasound-guided celiac plexus block or sham procedure. Adequate pain relief is defined as a 50% reduction in composite pain score from baseline, measured using the Brief Pain Inventory-Short Form, at 1 month post-intervention.
Time frame: 1 month
Technical success
Successful completion of EUS-CPB.
Time frame: Immediately after procedure
Pain scores measured using Visual Analog Scale.
Pain score measured using the Visual Analog Scale.
Time frame: 3 months
Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form.
Pain score measured using the Comprehensive Pain Assessment Tool-Short Form.
Time frame: 3 months
Quality of life assessment
Quality of life score measured using the Pancreatitis Quality of Life Instrument.
Time frame: 3 months
Opioid analgesic use
Opioid analgesic use measured in morphine equivalent dosage.
Time frame: 3 months
Procedure-related adverse events
Any adverse event occurring as a result of endoscopic intervention.
Time frame: 3 months
Disease-related adverse events
Any adverse event occurring as a result of underlying chronic pancreatitis.
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Time frame: 3 months
Hospital admissions for management of chronic pancreatitis.
Number of hospital admissions for management of chronic pancreatitis.
Time frame: 3 months
Length of hospitalization in any patient hospitalized
Length of hospitalization in any patient hospitalized with any adverse event or due to chronic pancreatitis.
Time frame: 3 months
Rate of cross-over to EUS-CPB in patients initially assigned to the sham group.
Rate of cross-over to EUS-CPB in patients initially assigned to the sham group.
Time frame: 3 months
Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis.
Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis.
Time frame: 3 months