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.

Timeline

Start

2014-12

Primary completion

2018-02-12

Completion

2018-02-12

Publications

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• Background Wilcox CM. Tinkering with a tarnished technique: isn't it time to abandon celiac plexus blockade for the treatment of abdominal pain in chronic pancreatitis? Clin Gastroenterol Hepatol. 2012 Feb;10(2):106-8. doi: 10.1016/j.cgh.2011.10.039. Epub 2011 Nov 9. No abstract available.
• Background Kozak LJ, Owings MF, Hall MJ. National Hospital Discharge Survey: 2002 annual summary with detailed diagnosis and procedure data. Vital Health Stat 13. 2005 Mar;(158):1-199.
• Background Gress F, Schmitt C, Sherman S, Ciaccia D, Ikenberry S, Lehman G. Endoscopic ultrasound-guided celiac plexus block for managing abdominal pain associated with chronic pancreatitis: a prospective single center experience. Am J Gastroenterol. 2001 Feb;96(2):409-16. doi: 10.1111/j.1572-0241.2001.03551.x.
• Background Drewes AM, Krarup AL, Detlefsen S, Malmstrom ML, Dimcevski G, Funch-Jensen P. Pain in chronic pancreatitis: the role of neuropathic pain mechanisms. Gut. 2008 Nov;57(11):1616-27. doi: 10.1136/gut.2007.146621. Epub 2008 Jun 19.
• Background Goodman AJ, Gress FG. The endoscopic management of pain in chronic pancreatitis. Gastroenterol Res Pract. 2012;2012:860879. doi: 10.1155/2012/860879. Epub 2012 Mar 5.
• Background Dumonceau JM, Delhaye M, Tringali A, Dominguez-Munoz JE, Poley JW, Arvanitaki M, Costamagna G, Costea F, Deviere J, Eisendrath P, Lakhtakia S, Reddy N, Fockens P, Ponchon T, Bruno M. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2012 Aug;44(8):784-800. doi: 10.1055/s-0032-1309840. Epub 2012 Jul 2.
• Background Gress F, Schmitt C, Sherman S, Ikenberry S, Lehman G. A prospective randomized comparison of endoscopic ultrasound- and computed tomography-guided celiac plexus block for managing chronic pancreatitis pain. Am J Gastroenterol. 1999 Apr;94(4):900-5. doi: 10.1111/j.1572-0241.1999.01042.x.
• Background Kaufman M, Singh G, Das S, Concha-Parra R, Erber J, Micames C, Gress F. Efficacy of endoscopic ultrasound-guided celiac plexus block and celiac plexus neurolysis for managing abdominal pain associated with chronic pancreatitis and pancreatic cancer. J Clin Gastroenterol. 2010 Feb;44(2):127-34. doi: 10.1097/MCG.0b013e3181bb854d.
• Background Schneider A, Lohr JM, Singer MV. The M-ANNHEIM classification of chronic pancreatitis: introduction of a unifying classification system based on a review of previous classifications of the disease. J Gastroenterol. 2007 Feb;42(2):101-19. doi: 10.1007/s00535-006-1945-4. Epub 2007 Mar 12.
• Background Varadarajulu S, Eltoum I, Tamhane A, Eloubeidi MA. Histopathologic correlates of noncalcific chronic pancreatitis by EUS: a prospective tissue characterization study. Gastrointest Endosc. 2007 Sep;66(3):501-9. doi: 10.1016/j.gie.2006.12.043. Epub 2007 Jul 20.
• Background Kleykamp M. Unemployment, earnings and enrollment among post 9/11 veterans. Soc Sci Res. 2013 May;42(3):836-51. doi: 10.1016/j.ssresearch.2012.12.017. Epub 2013 Jan 7.
• Background Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.

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