Clinical Trial: Celiac Plexus Block for Chronic Pancreatitis RCT

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Randomized Trial of EUS Guided Celiac Plexus Block for Chronic Pancreatitis

Brief 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 nee

Detailed Summary:

1.0 Background and Hypothesis: Chronic pancreatitis is an inflammatory disease of the pancreas characterized by painful scarring and loss of glandular function.The prevalence of chronic pancreatitis in the United States is estimated to be 0.2 to 5% and results in 86,000 hospitalizations. The majority of patients with chronic pancreatitis will develop significant abdominal pain which is debilitating and results in a significant burden on the health care system.

Multiple approaches, including pancreatic enzymes, narcotic analgesia, celiac plexus block and surgical ganglionectomy have been used to treat pancreatic pain with variable success. Injection of local anesthesia agents and steroids into the celiac plexus for pain control has been used for many years via both surgical and percutaneous approaches. Topical therapy theoretically prevents the conduction of painful stimuli from the pancreas and addresses inflammatory changes in the afferent nerves themselves. Splanchnic nerves pass from the pancreas to the thoracic root ganglia via the celiac ganglia which are the target for intervention. Nerve changes in chronic pancreatitis including perineural inflammation, altered diameter, and upregulation of pain neuropeptides (including Substance P) are associated with increased sensitivity to stimuli from the pancreas (distension and inflammation) as well as pain independent of stimuli (neuropathic). Endoscopic ultrasound allows for close proximity, high resolution assessment of the gastrointestinal tract wall and adjacent anatomic structures. Physicians are able to perform EUS-guided celiac plexus injections in the outpatient setting under conscious sedation. The EUS guided approach offers better visualization of the celiac region and direct access to the celiac plexus. EUS guided celiac plexus block is a core part of the routine care of patients at Los Angeles County Hospital wi
Sponsor: University of Southern California

Current Primary Outcome: Long Term CHANGE in Pain Scores [ Time Frame: 24 weeks ]

Primary outcomes will be the CHANGE pain score (as assessed by the visual-analogue-scale and M-ANNHEIM score assessed between time 0 and 24 weeks post procedure in those who undergo EUS without block (control) compared to those who undergo EUS with block


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hospital re-admission [ Time Frame: 24 weeks ]
    differences in number of hospital re-admissions for pancreatic pain assessed at 24 weeks between those who underwent the block and did not undergo the celiac block
  • CHANGE Pain medication requirements [ Time Frame: 24 weeks ]
    CHANGE in pain medication requirement 24 weeks following celiac block in those who underwent EUS guided celiac block compared to those who did not
  • Procedure Complications [ Time Frame: 2 weeks ]
    Post procedure complications include infection (defined as fever or increased WBC without an alternative cause), diarrhea (defined as 3 loose stools per day), or pancreatitis (defined as increased pain and lipase >3 X the upper limit of normal). Will be assessed 2 weeks after the procedure and compared between those who EUS with block compared to EUS without block


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: January 11, 2015
Date Started: December 2014
Date Completion: December 2017
Last Updated: April 18, 2017
Last Verified: April 2017