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

June 2, 2014 updated by: University of Alabama at Birmingham

EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Florida
      • Orlando, Florida, United States, 32803
        • Florida Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • EUS-CPN
No Intervention: Analgesic therapy alone
Will not receive ultrasound guided celiac plexus neurolysis (CPN); only standard analgesic therapy for pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
~ 2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)
Time Frame: ~2 year
~2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

AdventHealth

Investigators

  • Principal Investigator: Jayapal Ramesh, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (Estimate)

August 28, 2009

Study Record Updates

Last Update Posted (Estimate)

June 4, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F090528002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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