Clinical trial NCT02054910: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pancreatitis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Mean Quality of Life Score Between Each Group at 6 Months
timeFrame: 6 months post baseline
measure: Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
timeFrame: baseline to 6 months
measure: Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.
timeFrame: baseline to 6 months
measure: Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
timeFrame: baseline to 6 months
measure: % of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Charles M Wilcox, MD
role: PRINCIPAL_INVESTIGATOR
References: