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Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Florida Hospital
Information provided by (Responsible Party):
Shyam Varadarajulu, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00968175
First received: August 26, 2009
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.


Condition Intervention
Pain
Pancreatic Cancer
 Procedure: Ultrasound guided celiac plexus neurolysis (CPN)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy [ Time Frame: ~ 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL) [ Time Frame: ~2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1: CPN + analgesic therapy
Receives ultrasound guided celiac plexus neurolysis (CPN) in addition to standard analgesic therapy
 Procedure: Ultrasound guided celiac plexus neurolysis (CPN)
Initial procedure and rescue procedure if applicable
Other Name: EUS-CPN
No Intervention: Analgesic therapy alone
Will not receive ultrasound guided celiac plexus neurolysis (CPN); only standard analgesic therapy for pain management

Detailed Description:

The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the changes in reported pain severity between those who receive EUS-CPN in addition to analgesic therapy as compared to analgesic therapy alone.

The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female
  2. Age ≥19 yrs old
  3. Abdominal pain typical for pancreatic cancer ≥3/10
  4. Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
  5. Pancreatic cancer confirmed by FNA during EUS
  6. Inoperability of pancreatic cancer as determined during EUS or prior CT

Exclusion Criteria:

  1. Age < 19 yrs old
  2. Unable to safely undergo EUS for any reason
  3. Coagulopathy (prolongation of prothrombin time > 18 sec, thrombocytopenia <80,000 platelets/ml)
  4. Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
  5. Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
  6. Potential patient noncompliance (refusing to follow schedule of events)
  7. Active alcohol or other drug use or significant psychiatric illness
  8. Pregnant or breastfeeding
  9. Unable to consent
  10. Non-English speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968175

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Sponsors and Collaborators
University of Alabama at Birmingham
Florida Hospital
Investigators
Principal Investigator: Shyam Varadarajulu, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Shyam Varadarajulu, Principle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00968175     History of Changes
Other Study ID Numbers: F090528002
Study First Received: August 26, 2009
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Ultrasound guided celiac plexus neurolysis
CPN
Pancreatic Cancer
Pain Management

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013