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Acute Pancreatitis clinical trials

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NCT ID: NCT04870268 Completed - Acute Pancreatitis Clinical Trials

Late Phase Acute Pancreatitis: a Tailored Step-up Approach

TSA
Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

Several interventional and surgical procedures are available to treat moderate-to-critical acute pancreatitis (AP) in its late phase. The ongoing debate on these options, together with the scarcity of reported mid-term follow-up information in the Literature, prompted the investigators to conduct a review of our surgical experience, focused on those issues. The investigators reviewed retrospectively all the patients treated for moderate-to-critical AP according to Determinant-Based Classification (DBC), in the last nine years. Patients treated conservatively or operated within 4 weeks of the onset of the pancreatitis were excluded. All the included patients were managed following a "tailored" step-up approach, and divided into four groups, according to the first interventional procedure performed: percutaneous drainage (PD), endoscopic approach (END), internal derivation (INT), and necrosectomy (NE). In-hospital and mid-term follow-up variables, including a quality-of-life assessment, were analyzed and compared.

NCT ID: NCT04816877 Recruiting - Acute Pancreatitis Clinical Trials

Use of Patient-Controlled Analgesia in Acute Pancreatitis

PCA-AP
Start date: February 1, 2022
Phase:
Study type: Observational

Acute pancreatitis (AP) represents a critical health concern nationwide, with estimated 274,000 admissions annually and at a cost of 2.6 billion dollars. Current treatment strategies for AP are limited to supportive care with fluid resuscitation, analgesia, nutrition and prevention of end organ damage. Abdominal pain is often the predominant symptom in patients with AP and is treated with analgesics. As there is currently no disease-specific medical treatment to change the natural history of pancreatitis, pain control remains central to the treatment of AP. Among the analgesics, opioids have been shown to be provide safe and effective pain control in patients with AP. Current literature shows that there is no difference in the risk of pancreatitis complications or clinically serious adverse events between opioids and other analgesia options. Among hospitalized AP patients, adequate pain control often requires the use of intravenous (IV) opiates in the first 24-48 hours, which can later be transitioned to oral (PO) opioids. While there are various methods of delivering opioid medications such as IV, PO, and transdermal to name a few, IV opioids are commonly administered, either on a scheduled and/or on an as needed (PRN) basis as directed by the attending physician. In contrast to the conventional, method of physician directed IV opioid delivery, patient-controlled analgesia (PCA) is a form of IV opioid medication delivery in which the patient can rapidly titrate the opioid dose to manage variable levels of pain. This modality of opioid administration is often preferred by patients and has been widely used in postsurgical and obstetric patients to effectively treat their pain. PCA allows for faster intervention on pain limiting time to treatment and peak pain levels and has also been shown to decrease total opioid dose. However, there is limited evidence in published literature assessing the feasibility of using PCA to treat the pain of AP or comparing its efficacy and safety profile compared to the more traditional physician directed analgesia. One retrospective study has shown that use of PCA was surprisingly associated with longer hospital stays and higher rates of outpatient opioid use when compared to routine physician-directed analgesia (PDA), however there are no prospective trials to study this comparison. Hence, in this study, the investigators will compare the effects of using PCA among patients with AP to that of conventional PDA.

NCT ID: NCT04814693 Recruiting - Acute Pancreatitis Clinical Trials

Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis

RESOlVE
Start date: September 2, 2022
Phase: N/A
Study type: Interventional

In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. Necrotizing pancreatitis is characterized by the development of an acute necrotic collection and as this collection persists beyond 4 weeks, walled off necrosis (WON) encapsulates the collection. To date, this is treated by the step-up approach, which contains percutaneous drainage and minimally invasive video assisted retroperitoneal debridement (VARD) or endoscopic ultrasound (EUS) guided drainage followed by direct endoscopic necrosectomy (DEN). Different DEN techniques are available for the treatment of WON, however, there is a lack of effective endoscopic instruments to perform DEN. Recently, the first dedicated alternative to conventional DEN has been cleared for use, namely the EndoRotor® Resection System. This device is a powered mechanical debridement device intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. Previous (pilot and feasibility) studies showed promising results in terms of the amount of procedures, adverse events and length of hospital stay. Therefore, aim of this study is to assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off necrosis (WON) in a randomized controlled trial.

NCT ID: NCT04796311 Completed - Acute Pancreatitis Clinical Trials

Imunomodulation in Acute Pancreatitis

Start date: February 26, 2021
Phase:
Study type: Observational

Acute pancreatitis is an acute inflammatory pathology of the pancreas with activation of both innate and adaptive immune system, including T and B lymphocytes and release of inflammatory cytokines. We aim to characterize the circulating profile of T and B cells, its regulatory populations and B cell maturation, as well as inflammatory cytokines, in a prospective way of 50 patients with acute pancreatitis admitted to Hospital da Luz Lisboa. Blood samples will be collected at hospital admission, 48h, one month and 6 months after hospitalization of patients, relating these values to the severity of acute pancreatitis. Patients with acute pancreatitis in the previous 6 months, diabetes mellitus, pregnant women, uncontrolled comorbidity and terminal neoplasms will be excluded. A control group of 30 ambulatory individuals observed at the Hospital da Luz Lisboa will be recruited. Laboratory evaluation will be performed at the Immunology Laboratory of NOVA Medical School.

NCT ID: NCT04777812 Completed - Acute Pancreatitis Clinical Trials

Pancreatitis - Microbiome As Predictor of Severity

P-MAPS
Start date: February 17, 2020
Phase: N/A
Study type: Interventional

This study is a multicentric prospective study initiated and coordinated from the University Medical Centre Goettingen. The study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis.

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: 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: NCT04743570 Completed - Acute Pancreatitis Clinical Trials

Effects of Peripherally Acting µ-opioid Receptor Antagonists on Acute Pancreatitis

Start date: May 14, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study will investigate the effect of peripheral acting opioid antagonist (PAMORA) on the disease course of patients with acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating hospitalized patients with acute pancreatitis with a PAMORA (methylnaltrexone).

NCT ID: NCT04735055 Completed - Clinical trials for Artificial Intelligence

Artificial Intelligence Prediction for the Severity of Acute Pancreatitis

Start date: September 3, 2020
Phase:
Study type: Observational

The incidence of acute pancreatitis (AP) is increasing nowadays. The diagnosis of AP is defined according to Atlanta criteria with the presence of two of the following 3 findings; a) characteristic abdominal pain b) amylase and lipase values ≥3 times c) AP diagnosis in ultrasonography (USG), magnetic resonance imaging (MRI), or computerized tomography (CT) imaging. While 80% of the disease has a mild course, 20% is severe and requires intensive care treatment. Mortality varies between 10-25% in severe (severe) AP, while it is 1-3% in mild AP. Scoring systems with clinical, laboratory, and radiological findings are used to evaluate the severity of the disease. Advanced age (>70yo), obesity (as body mass index (BMI, as kg/m2), cigarette and alcohol usage, blood urea nitrogen (BUN) ≥20 mg/dl, increased creatinine, C reactive protein level (CRP) >120mg/dl, decreased or increased Hct levels, ≥8 Balthazar score on abdominal CT implies serious AP. According to the revised Atlanta criteria, three types of severity are present in AP. Mild (no organ failure and no local complications), moderate (local complications such as pseudocyst, abscess, necrosis, vascular thrombosis) and/or transient systemic complications (less than 48h) and severe (long-lasting systemic complications (>48h); organ insufficiencies such as lung, heart, gastrointestinal and renal). Although Atlanta scoring is considered very popular today, it still seems to be in need of revision due to some deficiencies in the subjects of infected necrosis, non-pancreatic infection and non-pancreatic necrosis, and the dynamic nature of organ failure. Even though the presence of 30 severity scoring systems (the most accepted one is the APACHE 2 score among them), none of them can definitely predict which patient will have very severe disease and which patient will have a mild course has not been discovered yet. Today, artificial intelligence (machine learning) applications are used in many subjects in medicine (such as diagnosis, surgeries, drug development, personalized treatments, gene editing skills). Studies on machine learning in determining the violence in AP have started to appear in the literature. The purpose of this study is to investigate whether the artificial intelligence (AI) application has a role in determining the disease severity in AP.