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

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

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 Overview

• Status: Recruiting
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Procedure: EUS-guided celiac plexus block; Procedure: Sham procedure

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.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara J Broome; Phone Number: 321-841-7031; Email: barbara.broome@orlandohealth.com
• Study Contact Backup: Name: Charles Melbern Wilcox, MD; Phone Number: 321-841-2431; Email: charles.wilcox@orlandohealth.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health
      • Contact: Barbara J Broome; Phone Number: 321-841-7031; Email: barbara.broome@orlandohealth.com
      • Contact: Charles Melbern Wilcox, MD; Phone Number: 321-841-2431; Email: charles.wilcox@orlandohealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endoscopic ultrasound-guided celiac plexus block; EUS-guided celiac plexus block will be performed.	Procedure: EUS-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.
Sham Comparator: Sham; Celiac plexus block will not be performed.	Procedure: Sham procedure; Celiac plexus will not be performed in this arm.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Estimated): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pancreatic Diseases; Chronic Disease; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 2103069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No