Prospective Study of Celiac Block Injection: 1 vs. 2

Phase 4

Completed

• Conditions: Chronic Pancreatitis; Pancreatic Cancer
• Interventions: Other: one injection into the celiac ganglion; Other: two injections into the celiac ganglion

• Registration Number: NCT00583479
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-31
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	one injection into the celiac ganglion	subjects who get one medication injection into the celiac ganglion during the EUS
B	two injections into the celiac ganglion	subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
change in medication use	at 24-hours after procedure and every week thereafter until the subject is no longer in the study
change is pain score	at 24-hours after procedure and every week thereafter until the subject is no longer in the study
complications related to CB	at 24-hours after procedure and every week thereafter until the subject is no longer in the study

Trial Locations

Locations (1)

Clarian Health: Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States