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Prospective Study of Celiac Block Injection: 1 vs. 2

NCT ID: NCT00583479

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pancreatitis Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

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

Group Type OTHER

one injection into the celiac ganglion

Intervention Type OTHER

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

B

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

Group Type OTHER

two injections into the celiac ganglion

Intervention Type OTHER

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

Interventions

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one injection into the celiac ganglion

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

Intervention Type OTHER

two injections into the celiac ganglion

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Indiana University

Principal Investigators

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Julia LeBlanc, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Clarian Health: Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22000795 (View on PubMed)

Other Identifiers

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0203-32

Identifier Type: -

Identifier Source: org_study_id