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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00968175

Enrollment

Registered

2009-08-28

Start date

2009-06-30

Completion date

2013-12-31

Last updated

2014-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Pancreatic Cancer

Keywords

Ultrasound guided celiac plexus neurolysis, CPN, Pancreatic Cancer, Pain Management

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

Interventions

PROCEDUREUltrasound guided celiac plexus neurolysis (CPN)

Initial procedure and rescue procedure if applicable

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)	~2 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026