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Acute Pancreatitis clinical trials

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NCT ID: NCT06080789 Recruiting - Acute Pancreatitis Clinical Trials

A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis

Start date: February 26, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test the safety and effectiveness of a single dose of RABI-767 given by endoscopic ultrasound (EUS) guided peripancreatic injection in participants with predicted severe acute pancreatitis. The main question the study aims to answer is: • Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection safe in patients with predicted severe acute pancreatitis. The study also aims to answer: • Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis. Study participants will be randomly assigned (like the flip of a coin) to receive a single dose of RABI-767 plus supportive care or supportive care only. The study sponsor will compare safety and efficacy data collected from participants who receive RABI-767 to participants who receive supportive care only to test if RABI-767 is safe and effective.

NCT ID: NCT06077188 Recruiting - Acute Pancreatitis Clinical Trials

EFFECT OF CHEWING GUM ON CONTROLLING NAUSEA/VOMITING AND THIRST IN PATIENTS WITH ACUTE PANCREATITIS

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Nausea and vomiting are one of the most common symptoms in acute pancreatitis. In addition to pharmacological methods for nausea and vomiting, non-pharmacological methods can also be used. Among these, anticipatory nausea and vomiting can be prevented by behaviors aimed at distracting attention. This study will be conducted to evaluate the effect of chewing gum on the severity of nausea-vomiting and thirst in patients with acute pancreatitis. The study will be conducted with a total of 60 patients, 30 intervention and 30 control. Patients in the intervention group will chew xylitol gum five times a day for three days. The patients' thirst and nausea and vomiting conditions will be examined.

NCT ID: NCT06023771 Recruiting - Acute Pancreatitis Clinical Trials

Invasive Intervention of Local Complications of Acute Pancreatitis

Start date: October 2023
Phase:
Study type: Observational

Strategies for invasive intervention in acute pancreatitis include sequential or combined use of multiple drainage and debridement modalities. The more widely used is the step-up approach, which requires an individualized and multidisciplinary (internal medicine, interventional radiology, endoscopy, surgery, critical care medicine, and nutritionists) approach. The available evidence from randomized controlled studies is from highly selected subject populations, and it is unclear whether the results can be applied to complex clinical situations in real clinics, and the optimal strategy for drainage of peripancreatic lesions in different patients still needs to be evaluated in the real world. This study intends to establish a prospective single-center cohort for real-world analysis to collect comprehensive clinic information and clinical outcomes, to evaluate the effectiveness and safety of existing intervention strategies, especially the timing and modality of interventions, in real-world clinical practice, and to explore the key factors affecting patient prognosis.

NCT ID: NCT05878236 Recruiting - Acute Pancreatitis Clinical Trials

iMmune SignAtures and Clinical outComes in AP

MoSAIC
Start date: March 6, 2023
Phase:
Study type: Observational

The MoSAIC study is a prospective, observational study designed to develop an early prediction tool for severe acute pancreatitis (SAP) and define a distinct immunologic profile compared to moderate acute pancreatitis (MAP). The aims are to validate a new multi-cytokine panel for early prediction of SAP and to identify the specific immune cells that correspond with cytokine signatures in early acute pancreatitis to characterize the immune pathways driving the development of SAP. Participants will provide blood samples and complete patient surveys and interviews within 36 hours of hospital presentation, at 48 hours, and hospital day 7 (if admitted). Data on hospital stay, medical history, clinical course, and severity of disease will be collected.

NCT ID: NCT05859633 Recruiting - Acute Pancreatitis Clinical Trials

Neutrophil/Lymphocyte Ratio in Acute Pancreatitis

Start date: May 30, 2023
Phase:
Study type: Observational

Acute pancreatitis (AP) is a disease characterized by dysfunction of pancreatic acinar cells, improper activation of trypsin, and subsequent destruction of pancreatic self-defense mechanisms, further exacerbating injury and damage of pancreatic cells. It is a rapidly developing inflammatory process of the pancreas, and the most common reasons are alcohol and gallstones.

NCT ID: NCT05817721 Recruiting - Acute Pancreatitis Clinical Trials

PROTon Pump Inhibitors and Stent OCclusion Rate Of Lumen Apposing Metal Stents

PROTOCOL
Start date: May 5, 2023
Phase:
Study type: Observational

The goal of this observational retrospective cohort study in combination with an expert study is to assess the clinical relevance and management of Lumen apposing metal stent (LAMS)-occlusion and LAMS-occlusion-related complications as well as the influence of proton pump inhibitors (PPI) on LAMS-occlusion. The main questions this study aims to answer are: - the individual management of LAMS-occlusion and LAMS-occlusion-related complications in the respective centers participating in the study. - if there is an association between PPI-intake and LAMS-occlusion. Participants for the retrospective cohort study will be enrolled retrospectively among European centers with expertise in pancreatology. The expert survey will be distributed European-wide to centers with special expertise in pancreatology.

NCT ID: NCT05781243 Recruiting - Acute Pancreatitis Clinical Trials

Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation

WATERLAND
Start date: June 19, 2023
Phase: Phase 4
Study type: Interventional

Background: Acute pancreatitis (AP) is an acute inflammatory disease of variable severity. Mild cases have an uncomplicated clinical course, but local and systemic complications occur in one-third of patients and are associated with a longer hospital stay, increased morbidity, increased hospital costs, and increased risk of death. Some evidence suggests that fluid resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on AP when compared to normal saline (NS), and may be associated with a decrease in severity, but randomized controlled trials showed conflicting results. The WATERLAND trial has been designed to investigate the efficacy and safety of fluid resuscitation using LR as compared with NS in patients with AP. Methods: The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based moderate fluid resuscitation. The primary outcome will be moderately severe to severe AP, according to the revision of the Atlanta classification. The primary safety outcome will be a composite variable involving any of the following: fluid overload, acute kidney injury, hyperkalemia, hypercalcemia, or acidosis. A total sample of 720 patients, 360 in the LR group and 360 in the NS group will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe to severe AP in LR group will be 17%. The frequency in the NS group is assumed to be 27% under the null hypothesis and 17% under the alternative hypothesis. The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level.

NCT ID: NCT05756504 Recruiting - Acute Pancreatitis Clinical Trials

"NSAIDs vs. Opiates: Which is More Effective in Managing Pain in Mild to Moderate Acute Pancreatitis?

Start date: February 22, 2023
Phase: Early Phase 1
Study type: Interventional

Acute pancreatitis is a painful and potentially life-threatening condition that affects the pancreas, a glandular organ responsible for producing digestive enzymes and hormones. The condition is typically characterized by sudden inflammation of the pancreas that can cause severe abdominal pain, nausea, and vomiting. Treatment for acute pancreatitis usually involves supportive care, pain management, and sometimes, hospitalization. Nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are two of the most commonly used classes of pain medication for the management of acute pancreatitis. While both drugs are effective in reducing pain, they have different mechanisms of action and potential side effects. NSAIDs work by reducing inflammation and pain by inhibiting the activity of cyclooxygenase (COX) enzymes, whereas opioids work by binding to specific receptors in the brain and spinal cord to block the transmission of pain signals. Despite their widespread use, there is a lack of consensus regarding which medication is more effective for the management of acute pancreatitis, particularly in mild to moderate cases. Some studies have suggested that NSAIDs may be more effective for reducing pain in acute pancreatitis, while others have suggested that opioids may be more effective in providing pain relief. Moreover, there is a concern regarding the potential for adverse events associated with the use of opioids, such as respiratory depression, addiction, and constipation. Therefore, this study aims to compare the efficacy and safety of NSAIDs and opioids in the management of mild to moderate acute pancreatitis. This will be a randomized clinical trial, which will involve the recruitment of patients with mild to moderate acute pancreatitis who will be randomized to receive either an NSAID or an opioid for pain management. The primary outcome of this study will be the reduction in pain score measured using a visual analogue scale (VAS) over a 72-hour period. The secondary outcomes will include adverse events associated with each medication, length of hospital stay, and the need for further interventions. This study has the potential to provide important insights into the optimal management of pain in mild to moderate acute pancreatitis, which can ultimately improve patient outcomes and reduce the burden of this condition on the healthcare system.

NCT ID: NCT05722678 Not yet recruiting - Acute Pancreatitis Clinical Trials

Study and Analysis of Acute Pancreatitis Complicated With COVID-19

Start date: February 15, 2023
Phase:
Study type: Observational

The goal of this observational study was to explore the complex relationship between changes in the intestinal microbiome and serum metabolites in patients with novel coronavirus infection and acute pancreatitis. The main questions it aims to answer are: Question 1: The changes of intestinal microbiota and serum metabolites in patients with novel coronavirus infection and acute pancreatitis. Question 2: The relationship between the changes in the intestinal microbiome and serum metabolites. Participants will be recruited according to certain criteria. The investigators plan to recruit 4 groups of 30 volunteers, 120 volunteers in total. It is divided into (a) AP patients without COVID-19 (normal group) (b) AP patients with COVID-19 (treatment group) (c) patients with COVID-19 infection (control group) (d) normal healthy people. The basic information of subjects, including age, sex, address, and enrollment time, was collected after enrollment. After completing the relevant preparations, start the experiment. First of all, the sample collection and detection. Blood samples were taken from 2-3ml of blood (biochemical tube) after admission or in the morning of the next day, centrifuged at 3000 rpm for 3 minutes, and stored at -80℃ within 1 hour after taking the serum; Fecal samples are stool samples retained after admission and before antibiotic use. Fecal samples need to be stored at -20℃ within one hour after collection and transferred to -80℃within 24 hours. After the retention of samples, the retained stool samples shall be tested for bacterial flora, and the blood samples shall be tested for serum metabolomics. After the test, the investigators will use the statistical software SPSS 22.0 for statistical analysis. At the same time, in order to determine the correlation between intestinal flora and clinical parameters, the investigators will use Permutation analysis of variance (PERMANOVA) to process the data.

NCT ID: NCT05651360 Completed - Acute Pain Clinical Trials

Diagnostic Performance of Low-Dose CT for Acute Abdominal Conditions

DETECT_Acute
Start date: December 7, 2022
Phase:
Study type: Observational

The goal of this non-inferiority observational study is to assess the diagnostic performance of low-dose CT with deep learning image reconstruction (DLIR) in adult participants with acute abdominal conditions. The main research question is: • Can low-dose CT with DLIR achieve the same diagnostic performance as standard CT for the diagnosis of acute abdominal conditions. Participants will be examined with an additional low-dose CT directly after the standard CT. Participant will be their own controls.