Celiac Plexus Block for Chronic Pancreatitis RCT

• Status: Terminated
• Trial end date: 2018-02-12
• Target enrollment: 0
• Participant gender: All

Summary

Rationale: Chronic pancreatitis is a chronic inflammatory disease of the pancreas which results in debilitating abdominal pain, decreased productivity and increased health care costs. Endoscopic ultrasound (EUS) guided celiac plexus block (CPB) is routinely used to treat pain related to chronic pancreatitis. While EUS guided neurolysis for pancreatic cancer has significant efficacy, the benefit of CPB for chronic pancreatitis pain is controversial and has not been studied in a rigorous manner.

Objective: To assess whether EUS guided celiac plexus block decreases suffering, hospitalization, and opiate requirements related to chronic pancreatitis pain.

Population: Patients undergoing EUS at Los Angeles County Hospital for painful chronic pancreatitis.

Methods: Patients undergoing EUS to evaluate chronic pancreatitis with a typical visual analogue pain score >3, regular opiate use, and M ANNHEIM chronic pancreatitis score >6 will be eligible.

Study Arms: Patients will be randomized to 1) diagnostic endoscopic ultrasound 2) endoscopic ultrasound with celiac plexus block

Study Outcomes: The primary outcome will be a decrease in chronic pancreatitis pain assessed by the visual analogue scale and M ANNHEIM system at 24 weeks compared to immediately prior to the block. The ability to work and conduct normal activities, opiate medication requirements, and a Careprep symptom assessment at 24 weeks will also be compared prior to the block.

Analytic Plan: The projected response rate to EUS guided CPB is 52%. Given known 30% placebo response in patients with pain related to chronic pancreatitis we anticipate that 83 patients will need to participate to demonstrate a difference. We aim to enroll 90 patients in this study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Treatments: Bupivacaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Presentation with upper abdominal pain suggestive of pancreatitis who are undergoing EUS for evaluation

• M ANNHEIM severity index of 6 or greater to be included

• Intermittent episodes of pain>3 requiring opiate medication

Exclusion Criteria:

• Patients who have allergic reactions to steroids or bupivacaine

• INR >1.6

• platelets <75

• decompensated cirrhosis

• incarcerated

• <18 years old

• unable to give informed consent

• peptic ulcer disease

• ongoing substance or alcohol use