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Clinical Trials/NCT00583479
NCT00583479CompletedPhase 4

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

Indiana University1 site in 1 country100 target enrollmentStarted: June 1, 2002Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

A

Other

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

Intervention: one injection into the celiac ganglion (Other)

B

Other

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

Intervention: two injections into the celiac ganglion (Other)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor Class
Other

Study Sites (1)

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