Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolys... | NCT00968175

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

NCT00968175

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Jun 4, 2014Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Pain
Pancreatic Cancer

Interventions

Ultrasound guided celiac plexus neurolysis (CPN)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Mar 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 26, 2009

First Submission Date that Met QC Criteria

Aug 27, 2009

First Posted Date

Aug 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2014

Last Update Posted Date

Jun 4, 2014Estimated

Name	Class
AdventHealth	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound guided celiac plexus neurolysis (CPN)	Procedure	Initial procedure and rescue procedure if applicable	Group 1: CPN + analgesic therapy

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jayapal Ramesh, MD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Florida Hospital

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D010190	Pancreatic Neoplasms
D000377	Agnosia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D004067	Digestive System Neoplasms

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