NCT00583479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

6.1 years

First QC Date

December 20, 2007

Last Update Submit

September 11, 2012

Conditions

Chronic PancreatitisPancreatic Cancer

Outcome Measures

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

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

Secondary Outcomes (3)

  • 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

Study Arms (2)

A

OTHER

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

Other: one injection into the celiac ganglion

B

OTHER

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

Other: two injections into the celiac ganglion

Interventions

one injection into the celiac ganglionOTHER

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

A
two injections into the celiac ganglionOTHER

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clarian Health: Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 22000795DERIVED

MeSH Terms

Conditions

Pancreatitis, ChronicPancreatic Neoplasms

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System Diseases

Study Officials

  • Julia LeBlanc, MD, MPH

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

June 1, 2002

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations

US(1)