EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis
Purpose
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.
Condition
- Chronic Pancreatitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Endoscopic ultrasound-guided celiac plexus block |
EUS-guided celiac plexus block will be performed. |
|
|
Sham Comparator Sham |
Celiac plexus block will not be performed. |
|
Recruiting Locations
Orlando, Florida 32806
More Details
- Status
- Recruiting
- Sponsor
- Orlando Health, Inc.
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.