Celiac Plexus Block for Chronic Pancreatitis RCT

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.

Conditions

• Pancreatitis, Chronic
• Pancreatitis

Interventions

PROCEDURE

Celiac Block with triamcinolone and bupivicaine

Endosonography of the pancreas performed following by analgesic injection

PROCEDURE

No Celiac Block

EUS but no celiac block performed

DRUG

Intra Plexus Triamcinolone and Bupivicaine Injection

Injection of Triamcinolone and Bupivicaine into celiac plexus for pain relief

Sponsors & Collaborators

• University of Southern California

  lead OTHER

Principal Investigators

• James Buxbaum, MD · Los Angels County Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2018-02-12

Completion

2018-02-12

Countries

• United States

Study Locations