CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
Primary Purpose
Chronic Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Celiac Plexus Block
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pancreatitis
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Celiac Plexus Block
Sham
Arm Description
Celiac Plexus Block will be administered following EUS
A celiac plexus block will not be administered for pain management
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean Quality of Life Score Between Each Group at 6 Months
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).
Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
Mean Mental State Between Groups Using the Beck's Depression Index at 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.
Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group
% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
Subjects will be asked about employment at 6 months post procedure
Full Information
NCT ID
NCT02054910
First Posted
January 29, 2014
Last Updated
January 9, 2017
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02054910
Brief Title
CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Celiac Plexus Block
Arm Type
Experimental
Arm Description
Celiac Plexus Block will be administered following EUS
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
A celiac plexus block will not be administered for pain management
Intervention Type
Procedure
Intervention Name(s)
Celiac Plexus Block
Intervention Description
Patients will receive celiac plexus block during endoscopy.
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
Patients will not receive celiac plexus block during endoscopy.
Primary Outcome Measure Information:
Title
Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
Description
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.
Time Frame
baseline to 6 months
Secondary Outcome Measure Information:
Title
Mean Quality of Life Score Between Each Group at 6 Months
Description
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).
Time Frame
6 months post baseline
Title
Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
Description
the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
Time Frame
baseline to 6 months
Title
Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.
Description
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.
Time Frame
baseline to 6 months
Title
Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
Description
The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group
Time Frame
baseline to 6 months
Title
% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
Description
Subjects will be asked about employment at 6 months post procedure
Time Frame
baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M Wilcox, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
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