Chronic Pancreatitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEUS-guided celiac plexus block
Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.
PROCEDURESham procedure
Celiac plexus will not be performed in this arm.
Sponsors
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Abdominal pain of at least 3 months duration and a VAS score ≥ 3, with or without the use of narcotic analgesics. * Diagnosis of chronic pancreatitis on EUS examination, with ≥ 5 features on EUS. * No other cause of abdominal pain
Exclusion criteria
* Age \< 18 years. * History of prior EUS-CPB. * Use of anticoagulants that cannot be discontinued for the procedure. * Clinically significant allergy to bupivacaine or triamcinolone. * Unable to obtain consent for the procedure from either the patient or LAR. * Intrauterine pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adequate pain relief | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores measured using Visual Analog Scale. | 3 months | Pain score measured using the Visual Analog Scale. |
| Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form. | 3 months | Pain score measured using the Comprehensive Pain Assessment Tool-Short Form. |
| Quality of life assessment | 3 months | Quality of life score measured using the Pancreatitis Quality of Life Instrument. |
| Opioid analgesic use | 3 months | Opioid analgesic use measured in morphine equivalent dosage. |
| Procedure-related adverse events | 3 months | Any adverse event occurring as a result of endoscopic intervention. |
| Technical success | Immediately after procedure | Successful completion of EUS-CPB. |
| Hospital admissions for management of chronic pancreatitis. | 3 months | Number of hospital admissions for management of chronic pancreatitis. |
| Length of hospitalization in any patient hospitalized | 3 months | Length of hospitalization in any patient hospitalized with any adverse event or due to chronic pancreatitis. |
| Rate of cross-over to EUS-CPB in patients initially assigned to the sham group. | 3 months | Rate of cross-over to EUS-CPB in patients initially assigned to the sham group. |
| Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis. | 3 months | Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis. |
| Disease-related adverse events | 3 months | Any adverse event occurring as a result of underlying chronic pancreatitis. |
Countries
United States
Contacts
Primary ContactCharles Melbern Wilcox, MD
Backup ContactBarbara J Broome
Outcome results
None listed