NCT06178315NARecruiting

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

Orlando Health, Inc.

Start Date

12/7/2023

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

PROCEDURE

EUS-guided celiac plexus block

PROCEDURE

Sham procedure

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Conditions

Chronic Pancreatitis

Locations

Orlando Health

Orlando, Florida 32806

United States