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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pain, Pancreatic Cancer

Intervention / Treatment
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* Procedure: Ultrasound guided celiac plexus neurolysis (CPN)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: CPN + analgesic therapy<br>Receives ultrasound guided celiac plexus neurolysis (CPN) in addition to standard analgesic therapy | Procedure: Ultrasound guided celiac plexus neurolysis (CPN)<br>* Initial procedure and rescue procedure if applicable<br>* Other names: EUS-CPN;|
| No Intervention: Analgesic therapy alone<br>Will not receive ultrasound guided celiac plexus neurolysis (CPN); only standard analgesic therapy for pain management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy |  |   2 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound guided celiac plexus neurolysis, Pancreatic Cancer, Pain Management, CPN