Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies
PancreatitisThe Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) Study, which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). No patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC. The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC).
The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis
Chronic PancreatitisAcute pancreatitis (AP) may develop to chronic pancreatitis (CP). In Finland, the ethiology is alcohol in about 80% of the cases. Several symptoms lower the quality of life in CP patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency. Recently, the investigators and others have found that vitamin D may protect from the formation of fibrosis on cellular level. The investigators hypothesized that after the first AP they may be able to protect the formation of fibrosis leading to CP with Vitamin D, and designed this RCT. The aim is to study whether the investigators can prevent CP with vitamin D substitute. In this randomized controlled patient study, the patients after their first AP are randomized to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of vitamin D substitute daily. The patients are examined by MRI/MRCP imaging and laboratory tests at the baseline after recovery from AP and yearly then after. Primary endpoint is the development of parenchymal changes possibly related to fibrosis. Secondary endpoints are the development of CP with Mannheim criteria, CP related complications and mortality. The first analysis will be done after 7 years. The enrollment will begin 26.9.2016
Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests
Chronic PancreatitisPancreatic Exocrine Insufficiency3 moreThe goal of this observational study is to improve the epidemiological data of pancreatic exocrine insufficiency in China, determine the FE-1 cut-off value for the classification of PEI, and explore the characteristic differences between T3cDM and type 2 diabetes mellitus in clinical symptoms and laboratory indicators.
Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis...
Chronic PancreatitisThis study will investigate the status of fatigue, psychological comorbidity and quality of life among patients with chronic pancreatitis in China and analyze their influencing factors.
Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Chronic PancreatitisRespiratory Insufficiency4 moreTo evaluate pulmonary function in chronic pancreatitis compared with healthy volunteers and patients with cirrhosis.
Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis.(START)
PancreatitisChronicThis study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their smoking cessation rate.
Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis...
Chronic PancreatitisPatients with chronic pancreatitis suffer from constant debilitating symptoms. They have complex needs and require specialist, multi-disciplinary care. The investigators have developed a mobile phone app for patients with chronic pancreatitis, called the SmartCP app - the first app of its kind for this patient group. What is SmartCP? SmartCP is an app that allows patients to log daily symptoms, diet, and physical activity for review at clinic. It creates a red-alert for action if there are worsening symptoms. A Monthly-Check-In feature looks for symptoms of new diabetes or pancreatic cancer. SmartCP provides education on every aspect of pancreatitis, as well as contact information for the clinical team and for important pancreatitis resources. To develop SmartCP, the investigators established a multidisciplinary steering committee. The study The investigators aim to conduct a feasibility study to determine if the SmartCP app is feasible in the management of patients with chronic pancreatitis, complementing current specialist healthcare. Specifically, they will investigate acceptability, retention, incidents, resources, app user statistics, as well as investigating the occurrence of crisis events, symptoms, escalating symptoms, new diagnoses of diabetes or pancreatic cancer, and the use of communication and education features.
An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus
Chronic PancreatitisDiabetes MellitusTo explore the risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus (PPDM-C).
The PASTEC Study: Endoscopic Stenting Versus Surgery for the Treatment of Bile Duct Stricture in...
Chronic PancreatitisBiliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and in these cases, endoscopy and surgery are the treatment modalities of choice. Morbid-mortality of these procedures is similar and physicians face the decision between endoscopy and surgery for this group of patients, with no randomized controlled trial available comparing these procedures. The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of surgical and endoscopic interventions in the management of bile duct stricture for chronic pancreatitis. The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical procedures, length of stay. Eighty-six patients need to be included.
Celiac Plexus Block for Chronic Pancreatitis RCT
PancreatitisChronic1 moreRationale: Chronic pancreatitis is a chronic inflammatory disease of the pancreas which results in debilitating abdominal pain, decreased productivity and increased health care costs. Endoscopic ultrasound (EUS) guided celiac plexus block (CPB) is routinely used to treat pain related to chronic pancreatitis. While EUS guided neurolysis for pancreatic cancer has significant efficacy, the benefit of CPB for chronic pancreatitis pain is controversial and has not been studied in a rigorous manner. Objective: To assess whether EUS guided celiac plexus block decreases suffering, hospitalization, and opiate requirements related to chronic pancreatitis pain. Population: Patients undergoing EUS at Los Angeles County Hospital for painful chronic pancreatitis. Methods: Patients undergoing EUS to evaluate chronic pancreatitis with a typical visual analogue pain score >3, regular opiate use, and M ANNHEIM chronic pancreatitis score >6 will be eligible. Study Arms: Patients will be randomized to 1) diagnostic endoscopic ultrasound 2) endoscopic ultrasound with celiac plexus block Study Outcomes: The primary outcome will be a decrease in chronic pancreatitis pain assessed by the visual analogue scale and M ANNHEIM system at 24 weeks compared to immediately prior to the block. The ability to work and conduct normal activities, opiate medication requirements, and a Careprep symptom assessment at 24 weeks will also be compared prior to the block. Analytic Plan: The projected response rate to EUS guided CPB is 52%. Given known 30% placebo response in patients with pain related to chronic pancreatitis we anticipate that 83 patients will need to participate to demonstrate a difference. We aim to enroll 90 patients in this study.