A Prospective Study of EUS Guided Celiac Block

NCT ID: NCT00583271

Last Updated: 2014-09-05

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

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-06-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.

Detailed Description

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Conditions

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Chronic Pancreatitis Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

subjects who are getting a celiac block for chronic pancreatitis

triamcinolone

Intervention Type DRUG

80mg of triamcinolone injected into the celiac ganglion during the EUS-CB

2

subjects who are getting a celiac block for pancreatic cancer

98% dehydrated alcohol

Intervention Type DRUG

10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB

Interventions

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triamcinolone

80mg of triamcinolone injected into the celiac ganglion during the EUS-CB

Intervention Type DRUG

98% dehydrated alcohol

10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB

Intervention Type DRUG

Other Intervention Names

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Kenalog 80mg

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing EUS-guided CB (for purposes other than this study) will be eligible to participate in this study.
* Patients with chronic pancreatitis and pancreatic cancer must have documented disease by CT, ERCP, or EUS.
* 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

Exclusion Criteria

* Patients that have had a previous celiac plexus block are eligible for this 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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Responsibility Role SPONSOR

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

Other Identifiers

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IRB #0205-04B

Identifier Type: -

Identifier Source: secondary_id

0205-04B

Identifier Type: -

Identifier Source: org_study_id

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