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

Orlando Health, Inc.

Status: Enrolling

Conditions: Chronic Pancreatitis

Treatments: Procedure: Sham procedure; Procedure: EUS-guided celiac plexus block

Study type: Interventional

Funder types: Other

Identifiers

NCT06178315

2103069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Endoscopic ultrasound-guided celiac plexus block

Active Comparator group

Description:

EUS-guided celiac plexus block will be performed.

Treatment:

Procedure: EUS-guided celiac plexus block

Sham

Sham Comparator group

Description:

Celiac plexus block will not be performed.

Treatment:

Procedure: Sham procedure