Clinical trial NCT00968175: Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer
Official title: EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Pancreatic Cancer
Keywords: Ultrasound guided celiac plexus neurolysis
CPN
Pancreatic Cancer
Pain Management
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: AdventHealth
First posted: 2009-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Eligibility criteria: 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

Primary outcomes:
measure: The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy
timeFrame: ~ 2 year
Secondary outcomes:
measure: To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)
timeFrame: ~2 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: University of Alabama at Birmingham
name: Jayapal Ramesh, MD
role: PRINCIPAL_INVESTIGATOR
References: