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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968175
• Other study ID #: F090528002
• Status: Completed
• Phase: N/A
• First received: August 26, 2009
• Last updated: June 2, 2014
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Ultrasound guided celiac plexus neurolysis (CPN)
Initial procedure and rescue procedure if applicable

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Florida Hospital	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy		~ 2 year	No
Secondary	To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)		~2 year	No