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Pancreatitis clinical trials

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NCT ID: NCT04761523 Recruiting - Acute Pancreatitis Clinical Trials

The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

EFFORT
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.

NCT ID: NCT04753255 Recruiting - Clinical trials for Chronic Pancreatitis

Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies, the PROCEED Study

Start date: April 1, 2021
Phase:
Study type: Observational

This study gathers information on patients at different stages of chronic pancreatitis to better understand the natural course and risk factors associated with pancreatitis. Chronic pancreatitis is a disease that occurs when the pancreas is inflamed (swollen and irritated) all of the time. It is important for doctors to diagnose chronic pancreatitis in the beginning stages of the disease. Over time, as chronic pancreatitis gets worse, the pancreas may stop working correctly. Since treatment options for advanced (end-stage) chronic pancreatitis are limited, patients with early-stage chronic pancreatitis or those at high risk of developing chronic pancreatitis are ideally suited for interventions to prevent the development of end-stage chronic pancreatitis and its associated complications. Information from this study may help researchers to develop lab tests for early diagnosis and prediction of disease progression, to understand disease mechanisms, and to discover genetic factors affecting susceptibility and progression.

NCT ID: NCT04750044 Recruiting - Clinical trials for Post-ERCP Pancreatitis

Refeeding in Post-ERCP Pancreatitis

Start date: February 18, 2021
Phase: N/A
Study type: Interventional

Endoscopic retrograde cholangio-pancreatography (ERCP) is the most commonly used technique for diagnosis and treatment in the treatment of bile duct diseases including bile duct cholelithiasis and malignant/benign biliary obstruction. In particular, ERCP is an essential procedure for the removal of bile duct gallstones and bile drainage in malignant/benign biliary obstruction patients. Among ERCP-related complications, especially "post-ERCP pancreatitis (PEP)", which occurs due to the anatomical structure of the pancreatic biliary system, statistically occurs in about 5-10% of patients who first received ERCP. It is known, and treatment for PEP is the same as treatment for general acute pancreatitis but is known to have a relatively worse prognosis. The basis of treatment for acute pancreatitis is a conservative treatment based on fasting and fluid treatment, and starting oral diet after abdominal pain and pancreatic enzyme levels (amylase/lipase) normalized. However, a recent study reported that early oral diet could improve the patient's prognosis. According to a systematic review of 11 randomized trial papers by Valerie et al., it was reported that the early diet had the effect of reducing hospital stay without increasing adverse events when comparing the prognosis of the early refeeding group and delayed refeeding group. This result is theoretically considered to be because the oral diet has the advantage of increasing intestinal permeability, gut motility and reducing the likelihood of pancreatic necrosis/ infection compared to the parenteral diet. As above, PEP has the same treatment method as general acute pancreatitis but is known to have a relatively worse prognosis. However, the effect of an early diet recently attempted in acute pancreatitis has not been reported in patients with PEP. Therefore, we investigate the effects of early and delayed diets on the prognosis of patients with PEP through a prospective multicenter study.

NCT ID: NCT04747990 Recruiting - Covid19 Clinical Trials

coMpliAnce With evideNce-based cliniCal Guidelines in the managemenT of Acute biliaRy pancreAtitis

MANCTRA-1
Start date: April 1, 2021
Phase:
Study type: Observational

Acute pancreatitis (AP) is an inflammatory disease of the pancreas, most commonly caused by gallstones, or excessive use of alcohol. It represents a management challenge and a significant healthcare burden. The incidence of AP ranges globally from 5 to 30 cases per 100.000 inhabitants/year, and there is evidence that the incidence has been rising in recent years. The overall case-fatality rate for AP is roughly 5%, and it is expectedly higher for more severe stages of the disease. In most cases (80%), the outcome of AP is rapidly favorable. However, acute necrotizing pancreatitis (ANP) may develop in up to 20% of cases, and is associated with significant rates of early organ failure (38%), needing some type of surgical/endoscopic intervention (38%) and death (15%). In the United States, AP is a leading cause of inpatient care among gastrointestinal conditions: more than 270.000 patients are hospitalized for AP annually, at an aggregate cost of over 2.5 billion dollars per year. In Europe, the UK incidence of AP is estimated as 15-42 cases per 100.000/year and is rising by 2.7% each year. Despite existing evidence-based practice guidelines for the management of biliary AP, clinical compliance with recommendations is poor, with studies on this field identifying major discrepancies between evidence-based recommendations and daily clinical practice. Audits about biliary AP have been performed in Italy, Germany, France, and England, with quite disappointing results. Indeed, in these audits, the treatment of biliary AP differed substantially from the recommendations. For example, less than 15% of the responders stated that they strictly followed all recommendations included in the guidelines in Germany and 25.8% of patients did not receive definitive treatment for biliary AP within 1 year in the UK. These findings support the view that publication alone of nationally or internationally developed and approved guidelines is insufficient to modify the practice of non-specialists and raises the question of how best to spread guideline recommendations. In 2020, the spread of the virus Covid-19 has represented a pandemic that also had a profound impact on the surgical community. There are many ways through which the outbreak of the Covid-19 pandemic could have influenced daily clinical practice for patients with biliary AP also leading to a failure to adhere to the recommendations coming from the guidelines, especially those regarding the early and definitive treatment with cholecystectomy or ERCP and sphincterotomy. First of all, the recommendation to postpone all non-urgent endoscopic procedures during the peak of the pandemic. Second, the recommendation to conservatively treat inflammatory conditions such as acute cholecystitis and acute appendicitis wherever possible. Since the clinical compliance with recommendations about AP is poor and the impact of implementing guideline recommendations in biliary AP has not been well studied on a global basis, we launched the MANCTRA-1 study with the aim to demonstrate areas where there is currently a sub-optimal implementation of contemporary guidelines on biliary AP. Moreover, we argue that during the Covid-19 pandemic the tendency to disregard the guidelines recommendations has been more marked than usual and we will try to find out if AP patients' care during the Covid-19 pandemic resulted in a higher rate of adverse outcomes compared to non-pandemic times due to the lack in the compliance of the guidelines. The MANCTRA-1 can identify a number of areas for quality improvement that will require new implementation strategies. Our aim is to summarize the main areas of sub-optimal care to provide the basis for introducing a number of bundles in the management of AP patients to be implemented during the next years. The primary objective of the study is to evaluate which items of the current AP guidelines if disregarded, correlate with negative clinical outcomes according to the different clinical presentations of the disease. Secondary objectives are to assess the compliance of surgeons worldwide to the most up-to-date international guidelines on biliary AP, to evaluate the medical and surgical practice in the management of biliary AP during the non-pandemic (2019) and pandemic Covid-19 periods (2020), and to investigate outcomes of patients with biliary AP treatment during the two study periods.

NCT ID: NCT04743479 Recruiting - Diabetes Clinical Trials

Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)

ESPRIT-AI
Start date: December 1, 2020
Phase:
Study type: Observational

Pancreatic cancer is one of the most fatal malignancies with a 5-year survival rate of only ~6%[1]. The reasons for this high mortality rate can be attributed to several factors, of which perhaps the most important is delayed diagnosis due to vague symptoms and consequently missed opportunities for surgical resection. Therefore, the ability to detect pancreatic cancer at an early, more curable stage is urgently needed. Identifying risk factors and biomarkers of early pancreatic cancer could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease. Thus, the investigators propose this longitudinal study entitled, "Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)" in order to generate clinical data sets and bank serial blood specimens of high risk individuals.

NCT ID: NCT04688645 Recruiting - Acute Pancreatitis Clinical Trials

Balanced Crystalloid Solutions for Acute Pancreatitis

Start date: May 1, 2020
Phase: Phase 4
Study type: Interventional

Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.

NCT ID: NCT04672642 Recruiting - Clinical trials for Pancreatitis, Chronic

Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment.

NCT ID: NCT04654377 Recruiting - Depression, Anxiety Clinical Trials

Personalized Education and Pain Response in Chronic Pancreatitis

PEPCP
Start date: June 29, 2021
Phase: N/A
Study type: Interventional

Pain mechanisms in chronic pancreatitis (CP) are heterogeneous and includes nociception, pancreatic neuropathy and central neuropathy/neuroplasty. These mechanisms could occur simultaneously in variable proportions and could explain why several patients develop recurrence of pain even after being treated by all the currently available modalities, such as antioxidants, endoscopic therapies and surgery. In the studies by the investigators over the past 2 years, they observed that persistent pain in these patients was associated with varying grades of depression and poor quality of life. This was accompanied by alteration in the metabolites in the brain (anterior cingulate cortex, prefrontal cortex, hippocampus, and basal ganglia) as evidenced in magnetic resonance spectroscopy (MRS) of the brain. These areas in the brain are responsible for pain modulation, long-term pain memory and emotional responses to pain. When the investigators counselled these patients and explained their disease and possible outcomes based on their own clinical course, imaging and treatment response (personalized education/counselling), they reported significant improvement in depression, quality of life parameters and, interestingly, also in pain. Further, there were changes in the metabolite parameters in the brain on MRS after personalized counselling/education that was more similar to that of healthy controls. This led to our hypothesis that better understanding of the disease and its outcomes by the patients could improve their coping capabilities and increase their pain thresholds. This could augment the pain responses of these patients to the other therapeutic modalities. We will conduct this single blinded, placebo controlled, randomized controlled trial on patients with documented CP of over 3 years duration, who had at least 5 episodes of abdominal pain of over the past 6 months.

NCT ID: NCT04647097 Recruiting - Acute Pancreatitis Clinical Trials

Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation

REAPPEAR
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Recurrence of acute pancreatitis (AP) is often facilitated by regular alcohol consumption and smoking. An applied lifestyle intervention focusing on the cessation of alcohol consumption and smoking might prevent the recurrence of AP. REAPPEAR Study is a randomized controlled trial and a cohort study focusing on the efficacy of the lifestyle intervention and the effect of quitting alcohol and smoking respectively.

NCT ID: NCT04553783 Recruiting - Acute Pancreatitis Clinical Trials

Exploration of Blood Biomarkers, Including Whole Blood Viscosity as a Prognostic Factor for Acute Pancreatitis

Start date: March 10, 2020
Phase:
Study type: Observational

This study aims to evaluate the usefulness of blood viscosity as a prognostic factor in patients with acute pancreatitis. The study design is a single-arm prospective cohort observational study. Blood biomarkers including blood viscosity, C-reactive protein, hematocrit, and phosphate are measured and the correlation with the severity of acute pancreatitis will be analyzed.