Pancreatic Endotherapy for Refractory Chronic Pancreatitis
Abstract
Objectives and Rationale: Chronic pancreatitis is a scarring condition of the pancreas that often results in debilitating pain. When pancreatic duct drainage appears to be impaired by the presence of a blocking stone or scar tissue, pancreatic endotherapy (procedures performed through the mouth using a lighted tube with special instruments to enter the pancreatic duct) is often offered in clinical practice. The rationale for this study is that while pancreatic endotherapy is logical, there are limited studies to suggest it helps patients with their pain. Furthermore, these procedures are costly and have potential risks. We are proposing a preliminary study to perform the first sham (like a placebo) study of pancreatic endotherapy in patients with chronic pancreatitis and evidence of impaired pancreatic duct drainage by radiology scans. The objectives of this study are to: (1) determine the feasibility of a sham-controlled pancreatic endotherapy trial and (2) optimize enrollment criteria and outcome measures for a subsequent, definitive study. Fiscal Year 2018 Peer Reviewed Medical Research Program Topic Areas with Area of Encouragement: (1) Topic Area: Pancreatitis. Area of encouragement: Research to improve understanding and management of complications of pancreatitis. A common complication of chronic pancreatitis is obstruction or blockage of pancreatic drainage. This may cause increased pressure within the pancreatic duct, which is one mechanism of pain for patients suffering from chronic pancreatitis. The proposed pilot study will improve our understanding of the impact of pancreatic endotherapy in alleviating pain, quality of life, and opioid utilization, among other outcomes important to patients with chronic pancreatitis. (2) Topic Area: Chronic pain management. Area of encouragement: Research to advance understanding of the impact of psychosocial factors and other comorbidities on pain chronification. Research on non-addictive methods to treat and manage chronic pain. Patients with chronic pancreatitis are likely to suffer from chronic abdominal pain. This may lead to pain-related disability, depression, opioid dependence, and other negative sequelae. Pancreatic endotherapy is an attractive option for the treatment of pain, since it does not require the use of potentially addictive medications and may have an immediate impact on pain and its sequelae. The proposed preliminary study will carefully measure pain and pain-related comorbidities at baseline and through follow-up, including the use of quantitative sensory testing. (3) Topic Area: Non-opioid pain management. Area of encouragement: Research to identify and address biopsychosocial aspects of pain. Development of non-opioid pain management therapies. For patients with chronic pancreatitis, the most debilitating symptom is abdominal pain. This is known to result in lower quality of life and disability, and may be complicated by depression, anxiety, and opioid dependence, among others. Pancreatic endotherapy represents a potential non-opioid intervention; while it is offered in clinical practice, the evidence supporting its effectiveness is limited. This pilot study will provide empirical evidence that may help physicians understand who is more likely to benefit; most importantly. Since this is a preliminary study, the data generated by this research will help with the design of future definitive studies of pancreatic endotherapy and perhaps other interventions to treat pain caused by chronic pancreatitis. Ultimate Applicability and Impact of the Research: The proposed research applies to patients suffering from chronic pancreatitis, a scarring condition of the pancreas that is often manifest by severe and debilitating abdominal pain. Many patients with painful chronic pancreatitis undergo pancreatic endotherapy, despite its unclear benefits. This preliminary research study will improve our understanding of the interact
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jul 16, 2019
- Source ID
- W81XWH1910256
Entities
People
- Gregory Cote
Organizations
- Medical University of South Carolina
- United States Army