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

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ClinicalTrials.gov Identifier: NCT02054910
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Charles Mel Wilcox, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Procedure: Celiac Plexus Block Procedure: Sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
Study Start Date : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


  4. 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

  5. % 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054910


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Charles M Wilcox, MD University of Alabama at Birmingham

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Responsible Party: Charles Mel Wilcox, MD, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02054910     History of Changes
Other Study ID Numbers: F130822012
First Posted: February 4, 2014    Key Record Dates
Results First Posted: February 28, 2017
Last Update Posted: February 28, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases