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NCT00583271 Clinical Trial

A Prospective Study of EUS Guided Celiac Block

Pancreatic Cancer Clinical Trial

Official title:
A Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) Effectiveness

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00583271
Other study ID # 0205-04B
Secondary ID IRB #0205-04B
Status Completed
Phase N/A
First received December 20, 2007
Last updated September 3, 2014
Start date June 2002
Est. completion date December 2012

Study information
Verified date September 2014
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 127
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• triamcinolone
80mg of triamcinolone injected into the celiac ganglion during the EUS-CB
• 98% dehydrated alcohol
10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB

Locations
Country Name City State
United States Clarian Health: Indiana University Hospital Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

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