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

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ClinicalTrials.gov Identifier: NCT00968175
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pain Pancreatic Cancer Procedure: Ultrasound guided celiac plexus neurolysis (CPN)

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial
Study Start Date : June 2009
Primary Completion Date : March 2013
Study Completion Date : December 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL) [ Time Frame: ~2 year ]

Eligibility Criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Jayapal Ramesh, MD University of Alabama at Birmingham
More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00968175     History of Changes
Other Study ID Numbers: F090528002
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: May 2014

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