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

NCT00968175 | Completed

• 1 other identifier: F090528002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain; Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)

  ~2 year

Study Arms (2)

Group 1: CPN + analgesic therapy

ACTIVE COMPARATOR

Receives ultrasound guided celiac plexus neurolysis (CPN) in addition to standard analgesic therapy

Procedure: Ultrasound guided celiac plexus neurolysis (CPN)

Analgesic therapy alone

NO INTERVENTION

Will not receive ultrasound guided celiac plexus neurolysis (CPN); only standard analgesic therapy for pain management

Interventions

Ultrasound guided celiac plexus neurolysis (CPN) PROCEDURE

Initial procedure and rescue procedure if applicable

Also known as: EUS-CPN

Group 1: CPN + analgesic therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• AdventHealth: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Pain; Pancreatic Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Jayapal Ramesh, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 28, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 4, 2014

Record last verified: 2014-05

Locations

US (2)