Extra-pancreatic manifestations reported in association with pancreatitis; an international survey report.

BACKGROUND/OBJECTIVES: Local and systemic manifestations have been reported in association with pancreatitis, anecdotally. However, a systematic collection on the prevalence of each of these symptoms in pancreatitis is lacking. We aimed to determine the prevalence of symptoms and diagnoses reported by a cohort of patients with pancreatitis, refer to as "extra pancreatic manifestation of pancreatitis". METHODS: Cross-sectional study approved by the IRB and administered through a REDCap survey by "Mission: Cure", a nonprofit organization. RESULTS: Of the 225 respondents analyzed; 89% were adults, 69% females, 89% Caucasians with 74% residing in the USA. 42% of children and 50% of adults reported exocrine pancreatic insufficiency while 8% of children and 26% of adults reported DM. Type 3c DM was reported in all children and 45% of adult DM cases. Children were diagnosed with genetic or hereditary pancreatitis more frequently compared to adults (33.3% versus 8%; p = <0.001). Significantly more symptoms and diagnoses were reported by adults when compared to children including nighttime sweats, bloating, or cramping, greasy or oily stools, feeling cold and GERD with p values of 0.002, 0.006, 0.046, 0.002 and 0.003 respectively. CONCLUSIONS: Adults with pancreatitis frequently report symptoms not known to be associated with pancreatitis. Studies investigating mechanisms for these associated symptoms should be explored.

Clinical Trials in Pancreatitis: Opportunities and Challenges in the Design and Conduct of Patient-Focused Clinical Trials in Recurrent Acute and Chronic Pancreatitis: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop.

ABSTRACT: Recurrent acute pancreatitis and chronic pancreatitis represent high morbidity diseases, which are frequently associated with chronic abdominal pain, pancreatic insufficiencies, and reduced quality of life. Currently, there are no therapies to reverse or delay disease progression, and clinical trials are needed to investigate potential interventions that would address this important gap. This conference report provides details regarding information shared during a National Institute of Diabetes and Digestive and Kidney Diseases-sponsored workshop on Clinical Trials in Pancreatitis that sought to clearly delineate the current gaps and opportunities related to the design and conduct of patient-focused trials in recurrent acute pancreatitis and chronic pancreatitis. Key stakeholders including representatives from patient advocacy organizations, physician investigators (including clinical trialists), the US Food and Drug Administration, and the National Institutes of Health convened to discuss challenges and opportunities with particular emphasis on lessons learned from trials in participants with other painful conditions, as well as the value of incorporating the patient perspective throughout all stages of trials.

Accelerating the Drug Delivery Pipeline for Acute and Chronic Pancreatitis: Summary of the Working Group on Drug Development and Trials in Chronic Pancreatitis at the National Institute of Diabetes and Digestive and Kidney Diseases Workshop.

The lack of effective therapeutic agents specifically tailored for chronic pancreatitis (CP) has hampered clinical care and negatively impacted patients' lives. New mechanistic insights now point to novel therapies, which involve both recently developed and/or repurposed agents. This working group focused on 2 main outcomes for CP: pain and progression of disease. The goal is to frame the essential aspects of trial design including patient-centered outcomes, proposed methods to measure the outcomes of pain and progression, and study design considerations for future trials to facilitate rapid drug development for patients with CP.