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


N/A
19 Years
N/A
Open (Enrolling)
Both
Pain, Pancreatic Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Outcome Measure:

The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy

Outcome Time Frame:

~ 2 year

Safety Issue:

No

Principal Investigator

Shyam Varadarajulu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

F090528002

NCT ID:

NCT00968175

Start Date:

June 2009

Completion Date:

August 2013

Related Keywords:

  • Pain
  • Pancreatic Cancer
  • Ultrasound guided celiac plexus neurolysis
  • CPN
  • Pancreatic Cancer
  • Pain Management
  • Pancreatic Neoplasms

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Florida HospitalOrlando, Florida  32803