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

University of Alabama at Birmingham60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Pain Pancreatic Cancer

Interventions

Ultrasound guided celiac plexus neurolysis (CPN)PROCEDURE

Initial procedure and rescue procedure if applicable

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Florida Hospital

Orlando, Florida, United States

Outcomes

Primary Outcomes

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 Outcomes

To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)

Time frame: ~2 year

Data from ClinicalTrials.gov

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