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Acute Pancreatitis clinical trials

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NCT ID: NCT06283160 Recruiting - Acute Pancreatitis Clinical Trials

Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy

PROMETHEE
Start date: March 1, 2024
Phase:
Study type: Observational

Pancreaticoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology. The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications. Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).

NCT ID: NCT06223594 Recruiting - Acute Pancreatitis Clinical Trials

Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

Start date: July 17, 2023
Phase:
Study type: Observational

Acute pancreatitis (AP) is a common disease of the gastrointestinal tract that can result in emotional, physical, and financial burdens on the patient.

NCT ID: NCT06179459 Recruiting - Acute Pancreatitis Clinical Trials

Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

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

Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis. Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.

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.