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CompletedNCT00583479Updated Sep 12, 2012

Prospective Study of Celiac Block Injection: 1 vs. 2

A Phase 4 interventional study of one injection into the celiac ganglion and two injections into the celiac ganglion in Chronic Pancreatitis and Pancreatic Cancer, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-12.

Sponsored by Indiana University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.

02

Conditions studied

  • Chronic Pancreatitis
  • Pancreatic Cancer
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block will be eligible to participate in this study. Chronic pancreatitis and pancreatic cancer must be measured and documented by prior CT, ERCP, or EUS.
  • Patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit survivability of the sedation given or the procedure.
  • Age > or = to 18 years
  • No evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc)
  • No evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc)
  • No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
  • Patient must provide signed written informed consent.
  • Patients that have had a previous celiac plexus block are eligible for this study

Exclusion criteria

Exclusion Criteria:

  • The patient's celiac trunk should be imaged clearly under endoscopic ultrasound. The patient's celiac plexus should be accessed easily with a needle for the medication injection. If this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Other
    A

    subjects who get one medication injection into the celiac ganglion during the EUS

    Other: one injection into the celiac ganglion

  • Other
    B

    subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS

    Other: two injections into the celiac ganglion

Interventions

  • Otherone injection into the celiac ganglion

    one injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer

  • Othertwo injections into the celiac ganglion

    two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer

06

What researchers measure

Primary outcomes

  1. Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region

    Time frame: 24-hour after the procedure; then every week thereafter until the subject is no longer in the study

Secondary outcomes

  1. change in medication use

    Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study

  2. change is pain score

    Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study

  3. complications related to CB

    Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study

07

Study locations

1 site
  • Clarian Health: Indiana University Hospital
    Indianapolis, Indiana 46202, United States
08

References and documents

Publications

  • LeBlanc JK, Al-Haddad M, McHenry L, Sherman S, Juan M, McGreevy K, Johnson C, Howard TJ, Lillemoe KD, DeWitt J. A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: one injection or two? Gastrointest Endosc. 2011 Dec;74(6):1300-7. doi: 10.1016/j.gie.2011.07.073. Epub 2011 Oct 13. PubMed 22000795 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00583479
Lead sponsor
Indiana University
First posted
Dec 31, 2007
Start date
Jun 2002
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Sep 12, 2012

Study contacts

Julia LeBlanc, MD, MPH
principal investigator · Indiana University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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