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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Procedure: Celiac Plexus Block
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celiac Plexus Block<br>Celiac Plexus Block will be administered following EUS | Procedure: Celiac Plexus Block<br>* Patients will receive celiac plexus block during endoscopy.<br>|
| Sham Comparator: Sham<br>A celiac plexus block will not be administered for pain management | Procedure: Sham<br>* Patients will not receive celiac plexus block during endoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 months post baseline | 
| 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. | baseline to 6 months | 
| 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. | baseline to 6 months | 
| 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 | baseline to 6 months | 
| % of Subjects in Each Group That Are Employed at 6 Months Post Procedure. | Subjects will be asked about employment at 6 months post procedure | baseline to 6 months |