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

Not Applicable

Recruiting

• Conditions: Chronic Pancreatitis

• Registration Number: NCT06178315
• Lead Sponsor: Orlando Health, Inc.

Brief 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.

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 Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-07
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of adequate pain relief	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Disease-related adverse events	3 months	Any adverse event occurring as a result of underlying chronic pancreatitis.
Length of hospitalization in any patient hospitalized	3 months	Length of hospitalization in any patient hospitalized with any adverse event or due to chronic pancreatitis.
Hospital admissions for management of chronic pancreatitis.	3 months	Number of hospital admissions for management of chronic pancreatitis.
Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis.	3 months	Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis.
Technical success	Immediately after procedure	Successful completion of EUS-CPB.
Pain scores measured using Visual Analog Scale.	3 months	Pain score measured using the Visual Analog Scale.
Quality of life assessment	3 months	Quality of life score measured using the Pancreatitis Quality of Life Instrument.
Opioid analgesic use	3 months	Opioid analgesic use measured in morphine equivalent dosage.
Procedure-related adverse events	3 months	Any adverse event occurring as a result of endoscopic intervention.
Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form.	3 months	Pain score measured using the Comprehensive Pain Assessment Tool-Short Form.
Rate of cross-over to EUS-CPB in patients initially assigned to the sham group.	3 months	Rate of cross-over to EUS-CPB in patients initially assigned to the sham group.

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States