EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female
- •Age ≥19 yrs old
- •Abdominal pain typical for pancreatic cancer ≥3/10
- •Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
- •Pancreatic cancer confirmed by FNA during EUS
- •Inoperability of pancreatic cancer as determined during EUS or prior CT
Exclusion Criteria
- •Age \< 19 yrs old
- •Unable to safely undergo EUS for any reason
- •Coagulopathy (prolongation of prothrombin time \> 18 sec, thrombocytopenia \<80,000 platelets/ml)
- •Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
- •Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
- •Potential patient noncompliance (refusing to follow schedule of events)
- •Active alcohol or other drug use or significant psychiatric illness
- •Pregnant or breastfeeding
- •Unable to consent
- •Non-English speaking
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)(~2 year)