Evaluation of Injection Techniques in Celiac Plexus Neurolysis

NCT02068677 | Completed

• 1 other identifier: 456550
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

1\. To evaluate the efficacy of EUS-CPN in subjects who experience a sympathetic response during injection when compared with subjects who do not experience sympathetic response during injection. EUS-CPN when performed in subjects who experience a sympathetic response during injection will have better pain relief when compared to subjects who do not experience a sympathetic response during injection.

Conditions

Pancreatic Cancer; Pain

Outcome Measures

Primary Outcomes (1)

• abdominal pain

  The primary endpoint of the study is abdominal pain. It will be assessed with a standardized 11-point continuous visual analog pain scale with "0" equaling no pain, "5" moderate pain and "10" worst pain ever. Before the procedure, patient will be instructed in the use of the pain scale by the research nurse. After the procedure, pain scores will be assessed by the clinical research nurse at the predetermined intervals. A complete response will be defined as an absence of abdominal pain requiring no pain medications. A partial response will be defined as a greater than 50% reduction in abdominal pain as assessed by the numerical 0-10 pain score. Failure will be defined as a reduction of ≤20% in pain score.

  within the first year post CPN

Study Arms (2)

sympathetic response

OTHER

This group will be composed of subjects who experience a heart rate and/or Blood Pressure change during injection.

Other: Sympathetic response

no sympathetic response

OTHER

This group will be made up of subjects that do not experience a vital sign change with injection for CPN.

Other: no sympathetic response

Interventions

Sympathetic response OTHER

Sympathetic response will be defined as change in heart rate by \>10 bpm and change in BP \<10mmHg.

sympathetic response

no sympathetic response OTHER

no Sympathetic response will be defined as change in heart rate by \<10 bpm and change in BP \<10mmHg.

no sympathetic response

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Abdominal pain typical for pancreatic cancer ( pain score ≥ 3/10)
• Abdominal CT consistent with diagnosis of pancreatic cancer
• Pancreatic cancer confirmed by EUS-FNA
• Inoperable pancreatic cancer as determined during EUS or prior CT

You may not qualify if:

• Age under 19 years
• Unable to safely undergo EUS for any reason
• Coagulopathy (Prothrombin time \> 18 secs, platelet count \< 80,000/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 intrabdominal disorder
• Noncompliance such that the patient would not return for subsequent follow-up
• Active alcohol or other drug use or significant psychiatric illness
• Unable to consent
• Non-English speaking

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Shyam Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: February 21, 2014
• Study Start: August 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)