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


Phase 4
18 Years
N/A
Not Enrolling
Both
Chronic Pancreatitis, Pancreatic Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region

Outcome Time Frame:

24-hour after the procedure; then every week thereafter until the subject is no longer in the study

Safety Issue:

No

Principal Investigator

Julia LeBlanc, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Institutional Review Board

Study ID:

0203-32

NCT ID:

NCT00583479

Start Date:

June 2002

Completion Date:

July 2008

Related Keywords:

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

Name

Location

Clarian Health: Indiana University Hospital Indianapolis, Indiana  46202