Prospective Study of Celiac Block Injection: 1 vs. 2

Pancreatic Cancer Clinical Trial

Official title:

A Prospective Study of Celiac Block Technique: One Injection or Two?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583479
• Other study ID #: 0203-32
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2007
• Last updated: September 11, 2012
• Start date: June 2002
• Est. completion date: July 2008

Study information

• Verified date: September 2012
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• 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
• 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

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region		24-hour after the procedure; then every week thereafter until the subject is no longer in the study	No
Secondary	change in medication use		at 24-hours after procedure and every week thereafter until the subject is no longer in the study	No
Secondary	change is pain score		at 24-hours after procedure and every week thereafter until the subject is no longer in the study	No
Secondary	complications related to CB		at 24-hours after procedure and every week thereafter until the subject is no longer in the study	Yes