EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of EUS-guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Procedure: EUS-guided celiac plexus block
* Procedure: Sham procedure


Participation Criteria
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Eligibility Criteria
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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.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic ultrasound-guided celiac plexus block<br>EUS-guided celiac plexus block will be performed. | Procedure: EUS-guided celiac plexus block<br>* Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.<br>|
| Sham Comparator: Sham<br>Celiac plexus block will not be performed. | Procedure: Sham procedure<br>* Celiac plexus will not be performed in this arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Successful completion of EUS-CPB. | Immediately after procedure | 
| Pain scores measured using Visual Analog Scale. | Pain score measured using the Visual Analog Scale. | 3 months | 
| Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form. | Pain score measured using the Comprehensive Pain Assessment Tool-Short Form. | 3 months | 
| Quality of life assessment | Quality of life score measured using the Pancreatitis Quality of Life Instrument. | 3 months | 
| Opioid analgesic use | Opioid analgesic use measured in morphine equivalent dosage. | 3 months | 
| Procedure-related adverse events | Any adverse event occurring as a result of endoscopic intervention. | 3 months | 
| Disease-related adverse events | Any adverse event occurring as a result of underlying chronic pancreatitis. | 3 months | 
| Hospital admissions for management of chronic pancreatitis. | Number of hospital admissions for management of chronic pancreatitis. | 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. | 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. | 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. | 3 months |