Skip to main content
OpenTrials
Completed

NCT Number: NCT00583479

Prospective Study of Celiac Block Injection: 1 vs. 2

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clarian Health: Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

one injection into the celiac ganglion

Other

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

Other

two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer

Primary outcomes

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

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

Secondary outcomes

  1. change in medication use

    Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study

  2. change is pain score

    Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study

  3. complications related to CB

    Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Dec 31, 2007
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.