Small Duct Chronic Pancreatitis Clinical Trial
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
| NCT number | NCT02054910 |
| Other study ID # | F130822012 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | January 29, 2014 |
| Last updated | March 9, 2015 |
| Start date | October 2013 |
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alabama at Birmingham |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in pain response over a 6 month period of time | Pain scores will be assessed over two points on the VAS over a 6 month period of time. Assessment will be by a standard 11 point continuous visual analog scale pain score. | 6 months | No |