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Celiac Plexus Block for Chronic Pancreatitis RCT

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ClinicalTrials.gov Identifier: NCT02399800
Recruitment Status : Terminated (Low enrollment)
First Posted : March 26, 2015
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
James Buxbaum, University of Southern California

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.


Condition or disease Intervention/treatment Phase
Pancreatitis, Chronic Pancreatitis Procedure: Celiac Block with triamcinolone and bupivicaine Procedure: No Celiac Block Drug: Intra Plexus Triamcinolone and Bupivicaine Injection Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of EUS Guided Celiac Plexus Block for Chronic Pancreatitis
Study Start Date : December 2014
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : February 12, 2018


Arm Intervention/treatment
Experimental: EUS with Celiac Block
Celiac Block with triamcinolone and bupivicaine Intra Plexus Triamcinolone and Bupivicaine Injection
Procedure: Celiac Block with triamcinolone and bupivicaine
Endosonography of the pancreas performed following by analgesic injection

Drug: Intra Plexus Triamcinolone and Bupivicaine Injection
Injection of Triamcinolone and Bupivicaine into celiac plexus for pain relief
Other Name: kenalog

Active Comparator: EUS without Celiac Block
Patients will undergo EUS but no celiac block will be performed
Procedure: No Celiac Block
EUS but no celiac block performed




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399800


Locations
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United States, California
Los Angeles County Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: James Buxbaum, MD Los Angels County Hospital

Publications:

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Responsible Party: James Buxbaum, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02399800     History of Changes
Other Study ID Numbers: HS-14-00134
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by James Buxbaum, University of Southern California:
pancreatitis, chronic
endosonography
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Bupivacaine
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action