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Prospective Study of Celiac Block Injection: 1 vs. 2

Primary Purpose

Chronic Pancreatitis, Pancreatic Cancer

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

one injection into the celiac ganglion

two injections into the celiac ganglion

About this trial

This is an interventional treatment trial for Chronic Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clarian Health: Indiana University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

subjects who get one medication injection into the celiac ganglion during the EUS

subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change in medication use

change is pain score

complications related to CB

Full Information

NCT ID

NCT00583479

First Posted

December 20, 2007

Last Updated

September 11, 2012

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT00583479

Brief Title

Prospective Study of Celiac Block Injection: 1 vs. 2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Indiana University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pancreatitis, Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

subjects who get one medication injection into the celiac ganglion during the EUS

Arm Title

Arm Type

Other

Arm Description

subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS

Intervention Type

Other

Intervention Name(s)

one injection into the celiac ganglion

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

two injections into the celiac ganglion

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

change in medication use

Time Frame

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

Title

change is pain score

Time Frame

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

Title

complications related to CB

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julia LeBlanc, MD, MPH

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clarian Health: Indiana University Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22000795

Citation

LeBlanc JK, Al-Haddad M, McHenry L, Sherman S, Juan M, McGreevy K, Johnson C, Howard TJ, Lillemoe KD, DeWitt J. A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: one injection or two? Gastrointest Endosc. 2011 Dec;74(6):1300-7. doi: 10.1016/j.gie.2011.07.073. Epub 2011 Oct 13.

Results Reference

derived

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Prospective Study of Celiac Block Injection: 1 vs. 2

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