Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis

Study Overview
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Brief Summary
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AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB). METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.

Detailed Description
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Inclusion criteria include: age>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain. Exclusion criteria include: pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (>1.5) or low platelet count (<75 cells/mm3), allergy to eggs or caine anesthetics.

Official Title
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A Randomized, Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Standard Plexus Injection vs. Direct Celiac Ganglia Block for Treatment of Pain in Chronic Pancreatitis.

Conditions
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Pancreatitis, Chronic, Abdominal Pain

Intervention / Treatment
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* Procedure: EUS-celiac ganglia block (EUS-CGB)
* Procedure: EUS-celiac plexus block (EUS-CPB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with chronic pancreatitis and referred for EUS-guided celiac plexus block with: age>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain. Exclusion Criteria: pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (>1.5) or low platelet count (<75 cells/mm3), allergy to eggs or caine anesthetics.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EUS-celiac plexus block (EUS-CPB)<br>This is the standard technique. In this approach, the needle is passed through the body of the stomach adjacent the celiac artery into the retroperitoneal space in 1 or 2 passes. The injectate (bupivacaine or alcohol) is injected and spreads through the retroperitoneal space, effectively bathing all the ganglia. | Procedure: EUS-celiac plexus block (EUS-CPB)<br>* In the arm of EUS-CPB, the procedure is going to be performed with the standard EUS-guided celiac plexus block with injection of bupivacaine into the retroperitoneal space.<br>|
| Active Comparator: EUS-celiac ganglia block (EUS-CGB)<br>This is a more recent technique which has been often used. In this procedure, the needle is inserted under EUS guidance directly into as many ganglia as possible. For celiac ganglia <1cm in diameter, the solution is injected into the central point; for those ≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn. Injections are continued until an echogenic pattern is produced over the entire celiac ganglia. | Procedure: EUS-celiac ganglia block (EUS-CGB)<br>* The intervention technique of EUS-CGB is the realization of EUS-guided celiac block with injection of bupivacaine directly into the ganglia for patients with chronic pancreatitis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | The primary endpoint will be pain relief at 1 week after the block, defined as a decrease of 3 or more points in the VAS scale measuring average pain over past week. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | Decrease in pain to 1 or 0. | 1 week | 
| Duration of pain relief | Duration of pain relief will be assessed during a 2-month follow-up. | up to 2 months | 
| Opioid consumption | Assess the opioid consumption in up to 2 months after endoscopic therapy. | up to 2 months | 
| Adverse effects | Assess the incidence of adverse effects after endoscopic therapy. | in up to 2 months |