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Endoscopic Ultrasound (EUS)-Guided Celiac Plexus Neurolysis (CPN) in the Management of Pain in Abdominal Non-pancreatic Malignancies


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

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Trial Information

Endoscopic Ultrasound (EUS)-Guided Celiac Plexus Neurolysis (CPN) in the Management of Pain in Abdominal Non-pancreatic Malignancies


Inclusion Criteria:



- Diagnosis of an unresectable, non-pancreatic malignancy, including gastric, small
intestinal, or proximal colonic malignancies, as well as malignancies of the liver
and bile ducts (based on above celiac plexus innervations)

- Pain directly related to the primary malignant process, as determined by the
referring oncologist

- Pain determined to be refractory to standard medical therapy, or when the medical
therapy is ineffective due to certain limitations (such as severe constipation), as
determined by the referring oncologist

- Willingness to undergo EUS-guided CPN

- Age > 18 years

- ECOG performance status of grades 0-3 [7]

- The patient will need to sign informed consent prior to inclusion in this study

Exclusion Criteria:

- Unable or unwilling to undergo an EUS-guided CPN

- Contraindication to anesthesia, as determine during the preoperative clearance
process

- Refractory coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000), or
aspirin and/or clopidogrel use within 7 days of procedure

- Current pregnancy

- Prior celiac plexus block/neurolysis

- Allergy to local anesthetics

- ECOG performance status of grade 4 or higher

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Difference between the mean pain score prior to and 1 month after the procedure, as determined by the Brief Pain Inventory (BPI)

Outcome Description:

The BPI will be filled out just prior to and 1 month after the procedure to assess the difference in the mean pain score after the procedure

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Raj N Keswani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU protocol #0917 (eIRB 20311)

NCT ID:

NCT01166529

Start Date:

August 2010

Completion Date:

June 2013

Related Keywords:

  • Pain
  • Cancer

Name

Location

Northwestern Memorial HospitalChicago, Illinois  60611