CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

January 9, 2017 updated by: Charles Mel Wilcox, MD, University of Alabama at Birmingham

Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess pain response to EUS guided celiac plexus block treatment compared to no treatment. The Visual Analog Scale (VAS) is the primary measure. Secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of EUS-CPB on overall mental state using the Beck's Depression Index, and to assess the effect of EUS-CBP on health care utilization and on employment.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Celiac Plexus Block
Celiac Plexus Block will be administered following EUS
Procedure: Celiac Plexus Block
Patients will receive celiac plexus block during endoscopy.
SHAM_COMPARATOR: Sham
A celiac plexus block will not be administered for pain management
Procedure: Sham
Patients will not receive celiac plexus block during endoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
Time Frame: baseline to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Quality of Life Score Between Each Group at 6 Months
Time Frame: 6 months post baseline
The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life).
6 months post baseline
Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
Time Frame: baseline to 6 months
the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
baseline to 6 months
Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.
Time Frame: baseline to 6 months

The Beck's Depression scale was used to indicate subject's depression:

0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
baseline to 6 months
Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
Time Frame: baseline to 6 months
The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group
baseline to 6 months
% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
Time Frame: baseline to 6 months
Subjects will be asked about employment at 6 months post procedure
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (ESTIMATE)

February 4, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F130822012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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