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

Chronic Pancreatitis Clinical Trial

— EPOCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178315
• Other study ID #: 2103069
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Orlando Health, Inc.
• Contact: Charles Melbern Wilcox, MD
• Phone: 321-841-2431
• Email: Charles.Wilcox[@]orlandohealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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 procedure
Celiac plexus will not be performed in this arm.

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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