A Prospective Study of EUS Guided Celiac Block

NCT00583271 | Completed

• 2 other identifiers: 0205-04BIRB #0205-04B
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pancreatitis; Pancreatic Cancer

Study Arms (2)

1

subjects who are getting a celiac block for chronic pancreatitis

Drug: triamcinolone

2

subjects who are getting a celiac block for pancreatic cancer

Drug: 98% dehydrated alcohol

Interventions

triamcinolone DRUG

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

Also known as: Kenalog 80mg

1

98% dehydrated alcohol DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block.

You may qualify if:

• 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

You may not qualify if:

• Patients that have had a previous celiac plexus block are eligible for this study

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Clarian Health: Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatic Neoplasms

Interventions

Triamcinolone; Triamcinolone Acetonide; Ethanol

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Alcohols; Organic Chemicals

Study Officials

• Julia LeBlanc, MD, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: June 1, 2002
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

US (1)