A Prospective Study of EUS Guided Celiac Block

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00583271
First received: December 20, 2007
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.


Condition Intervention
Chronic Pancreatitis
Pancreatic Cancer
Drug: triamcinolone
Drug: 98% dehydrated alcohol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) Effectiveness

Resource links provided by NLM:


Further study details as provided by Indiana University:

Estimated Enrollment: 127
Study Start Date: June 2002
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
subjects who are getting a celiac block for chronic pancreatitis
Drug: triamcinolone
80mg of triamcinolone injected into the celiac ganglion during the EUS-CB
Other Name: Kenalog 80mg
2
subjects who are getting a celiac block for pancreatic cancer
Drug: 98% dehydrated alcohol
10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block.

Criteria

Inclusion Criteria:

  • Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing EUS-guided CB (for purposes other than this study) will be eligible to participate in this study.
  • Patients with chronic pancreatitis and pancreatic cancer must have documented disease by CT, ERCP, or EUS.
  • 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

Exclusion Criteria:

  • Patients that have had a previous celiac plexus block are eligible for this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583271

Locations
United States, Indiana
Clarian Health: Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Julia LeBlanc, MD, MPH Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00583271     History of Changes
Other Study ID Numbers: 0205-04B, IRB #0205-04B
Study First Received: December 20, 2007
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014