NCT02399800

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 need to participate to demonstrate a difference. We aim to enroll 90 patients in this study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

3.2 years

First QC Date

January 11, 2015

Last Update Submit

February 12, 2018

Conditions

Pancreatitis, ChronicPancreatitis

Keywords

pancreatitis, chronicendosonography

Outcome Measures

Primary Outcomes (1)

  • Long Term CHANGE in Pain Scores

    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

    24 weeks

Secondary Outcomes (3)

  • Hospital re-admission

    24 weeks

  • CHANGE Pain medication requirements

    24 weeks

  • Procedure Complications

    2 weeks

Study Arms (2)

EUS with Celiac Block

EXPERIMENTAL

Celiac Block with triamcinolone and bupivicaine Intra Plexus Triamcinolone and Bupivicaine Injection

Procedure: Celiac Block with triamcinolone and bupivicaineDrug: Intra Plexus Triamcinolone and Bupivicaine Injection

EUS without Celiac Block

ACTIVE COMPARATOR

Patients will undergo EUS but no celiac block will be performed

Procedure: No Celiac Block

Interventions

Celiac Block with triamcinolone and bupivicainePROCEDURE

Endosonography of the pancreas performed following by analgesic injection

EUS with Celiac Block
No Celiac BlockPROCEDURE

EUS but no celiac block performed

EUS without Celiac Block
Intra Plexus Triamcinolone and Bupivicaine InjectionDRUG

Injection of Triamcinolone and Bupivicaine into celiac plexus for pain relief

Also known as: kenalog
EUS with Celiac Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (13)

  • Sarles H. Etiopathogenesis and definition of chronic pancreatitis. Dig Dis Sci. 1986 Sep;31(9 Suppl):91S-107S. doi: 10.1007/BF01295992.

    PMID: 3525051BACKGROUND

  • 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.

    PMID: 22079511BACKGROUND

  • 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.

    PMID: 15853196BACKGROUND

  • 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.

    PMID: 11232683BACKGROUND

  • 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.

    PMID: 18566105BACKGROUND

  • 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.

    PMID: 22550479BACKGROUND

  • 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.

    PMID: 22752888BACKGROUND

  • 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.

    PMID: 10201454BACKGROUND

  • 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.

    PMID: 19826273BACKGROUND

  • 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.

    PMID: 17351799BACKGROUND

  • 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.

    PMID: 17640639BACKGROUND

  • 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.

    PMID: 23521998BACKGROUND

  • 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.

    PMID: 7749697BACKGROUND

MeSH Terms

Conditions

Pancreatitis, ChronicPancreatitis

Interventions

TriamcinoloneTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • James Buxbaum, MD

    Los Angels County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2015

First Posted

March 26, 2015

Study Start

December 1, 2014

Primary Completion

February 12, 2018

Study Completion

February 12, 2018

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

US(1)