NCT02054910

Brief Summary

This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 28, 2017

Completed
Last Updated

February 28, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

January 29, 2014

Results QC Date

April 22, 2016

Last Update Submit

January 9, 2017

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Response Over a 6 Month Period of Time Using the VAS Score

    Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.

    baseline to 6 months

Secondary Outcomes (5)

  • Mean Quality of Life Score Between Each Group at 6 Months

    6 months post baseline

  • Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline

    baseline to 6 months

  • Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.

    baseline to 6 months

  • Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure

    baseline to 6 months

  • % of Subjects in Each Group That Are Employed at 6 Months Post Procedure.

    baseline to 6 months

Study Arms (2)

Celiac Plexus Block

EXPERIMENTAL

Celiac Plexus Block will be administered following EUS

Procedure: Celiac Plexus Block

Sham

SHAM COMPARATOR

A celiac plexus block will not be administered for pain management

Procedure: Sham

Interventions

Celiac Plexus BlockPROCEDURE

Patients will receive celiac plexus block during endoscopy.

Celiac Plexus Block
ShamPROCEDURE

Patients will not receive celiac plexus block during endoscopy.

Sham

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
  • Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).

You may not qualify if:

  • Age \<19 years
  • Unable to safely undergo EUS for any reason
  • Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml)
  • Unable to consent
  • Non-English speaking patients.
  • Previously undergone CPB
  • Pregnancy and Breast feeding
  • Patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts.
  • Previous pancreatic surgery
  • Previous pseudocyst drainage
  • Other documented causes of abdominal pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jaypal Ramesh
Organization
University of Alabama at Birmingham
jramesh@uab.edu
205-975-9564

Study Officials

  • Charles M Wilcox, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 4, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 28, 2017

Results First Posted

February 28, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)