Clinical Research Directory

Bowel Sound in Predicting the Severity of Acute Pancreatitis: Protocol of a Prospective, Multi-center Study

Introduction: Acute pancreatitis (AP) is a common condition, with 20% of cases progressing to severe acute pancreatitis (SAP), which is associated with a poor prognosis. Early identification of patients likely to progress to SAP is crucial for timely intervention. This study aims to use bowel sound monitoring to predict early progression to SAP in AP patients. Methods and analysis: This study is a prospective, multi-center prognostic study . Investigators will consecutively recruit newly diagnosed acute pancreatitis (AP) patients at emergency departments across three centers from December 2023. Upon enrollment, each patient will undergo continuous bowel sound monitoring for at least 48 hours using standardized equipment and procedures. The primary outcome is the occurrence of SAP during hospitalization. Collected bowel sound data will be analyzed by an unsupervised automated algorithm to estimate a bowel sound activity index, which serves as the main diagnostic indicator for SAP. This process will be fully blinded to patients' SAP status. Investigators will calculate the ROC curve and area under the curve (AUC) for the bowel sound activity index's ability to diagnose SAP. Additionally, this study will perform exploratory analyses on differences in gut microbiota and serum intestinal permeability markers (diamine oxidase, D-lactic acid, and bacterial endotoxin) between patients with and without SAP. Investigators will also assess whether bowel sound monitoring can reflect these inter-group differences. Strengths and limitations of the study: 1. Our research aims to monitor bowel sounds in real-time and dynamically, providing an objective tool for monitoring intestinal activity in AP patients. 2. Our research might offer an objective tool to evaluate bowel sounds, aiding in assessing AP patients' intestinal function and complementing existing score systems like the modified Marshall score. 3. By detecting bowel sounds in the early stage of AP, investigators could better monitor intestinal function, which might aid in predicting the prognosis of AP patients. 4. Our monitoring system's main limitation is its difficulty in pinpointing bowel sound changes in specific intestinal segments due to its detection across the entire abdomen.

Methodist Acute Pancreatitis Protocol

The overall goal of this ongoing registry study is to optimize initial evaluation and treatment of patients with AP according to recommended guidelines, the Methodist Acute Pancreatitis Protocol (MAPP), which were implemented in January 2015.

Retrospective Analysis of Acute Pancreatitis After Percutaneous Mechanical Thrombectomy In Treatment Of Thrombotic Disorders

Acute pancreatitis is a rare complication after percutaneous mechanical thrombectomy in treatment of thrombotic disorders. The objectives of this study include: (1) Determine the incidence and severity of acute pancreatitis after percutaneous mechanical thrombectomy; (2) Identify patient/procedural risk factors; (3) Evaluate clinical outcomes; (4) Develop a diagnosis and treatment pathway.

AI-Powered Precision Decision-Making for Pancreatic Diseases

This multicenter clinical trial evaluates an artificial intelligence (AI) system designed to assist in the diagnosis and management of pancreatic diseases. Using contrast-enhanced CT scans, the study compares the AI's recommendations against the decisions of experienced clinicians to verify the system's accuracy and safety in a real-world setting. Patients are categorized into three management groups: Intervention (surgery/treatment), Intensive Surveillance (close monitoring), or Routine Surveillance (standard follow-up). The primary goal is to determine if the AI system can reliably classify patients, reduce the risk of missing malignant lesions, and prevent unnecessary surgeries, thereby improving clinical decision-making for pancreatic conditions.

Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis

The goal of this randomized control trial is to assess whether nasojejunal feed is better than oral nutrition in patients who are undergoing endoscopic cystogastrostomy of walled off necrosis following acute pancreatitis. It will also try to answer, the incidence of infections and feed tolerance. The main question it tries to answer is 1. whether nasojejunl feed is better than oral feed in patients undergoing endoscopic cystogastrostomy in walled off necrosis following acute pancreatitis 2. How much infections they develop, whether they are able to tolerate the feed, weight gain and reintervention rates in each group

Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.

Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.

Comparison of MIPPED-C and Surgical Necrosectomy in Pancreatic Necrosis Outcomes

This study is a retrospective, single-center, pre-post controlled clinical study. Patients (n=48) who underwent the MIPPED-C surgical procedure after January 1, 2019 were designated as the treatment group. Patients who were admitted to the hospital from January 1, 2014 to December 31, 2018 and underwent traditional open surgery were retrospectively evaluated by surgeons, radiologists, and interventionalists, and then matched for propensity score with a 1:2 ratio. 96 patients who underwent traditional open surgery were selected as the control group. The treatment group underwent the MIPPED-C surgery, while the control group underwent the traditional open necrotic tissue debridement procedure. The differences in inflammatory indicators, SIRS response, immune indicators, organ function indicators, and imaging changes of the two groups of patients at the time of admission, before the operation, and after the operation were retrospectively collected. The survival status, postoperative complications, re-intervention status, hospital stay, ICU stay, and hospitalization costs of the two groups of patients after the operation were also collected.

Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis

The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.

Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

Hypertriglyceridemia-associated acute pancreatitis (HTG-AP) is the second leading cause in China and is receiving increasing global attention. Research on HTG-AP has been hindered by the heterogeneity and complexity of the disease, as well as the limitations of prior single-center studies with small sample sizes, inadequate collection of clinical data, lack of sustainable follow-up, and insufficient tools for large-scale data collection, analysis, and biomarker testing. To address these unique challenges and leverage the opportunity to gain a deeper understanding of HTG-AP, the China Hypertriglyceridemia Pancreatitis Study Group (CHPSG) was initiated in April 2023 as a multi-center collaboration. By utilizing the advantages of multi-center studies, such as external validity and larger sample sizes, CHPSG aims to investigate the prevalence, clinical characteristics, natural history, and risk factors of HTG-AP in China. The consortium will also explore the differences between HTG-AP and other etiologies of pancreatitis, with an emphasis on systemic and local complications, recurrence, and long-term quality of life. Through its phased approach, CHPSG seeks to develop targeted strategies for the prevention and treatment of HTG-AP, ultimately improving patient outcomes.

Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis

The goal of this observational study is to learn about post-acute pancreatitis diabetes mellitus (PPDM-A). The main questions it aims to answer are: 1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies the same? 2. Are alterations in endocrine and exocrine secretory function in patients with acute pancreatitis associated with all-round outcomes? All patients with acute pancreatitis have been given the standardized treatment for the condition. Investigators will compare the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies in patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) to explore the association between alterations in endocrine and exocrine secretory function and all-round outcomes.

Dextran 40 Plus Ringer's Lactate Vs. Ringer's Lactate Alone for Fluid Resuscitation in Acute Pancreatitis

This clinical trial aims to learn if a combination of Dextran 40 and Ringer's lactate solution can improve fluid resuscitation in mild and moderate acute pancreatitis (AP) and prevent complications. The main questions it aims to answer are: Does early fluid resuscitation with Dextran 40 plus Ringer's lactate improve patient outcomes compared to Ringer's alone? Does this treatment reduce inflammation, organ failure, and the need for intensive care unit (ICU) admission? Researchers will compare Dextran 40 plus Ringer's lactate to Ringer's alone to see if the combination therapy is more effective in reducing disease severity and complications. Participants will: Receive either Dextran 40 plus Ringer's lactate (1:3 ratio) or Ringer's lactate alone. Have blood tests every 24 hours to measure inflammation and organ function. Be monitored for changes in disease severity, need for ICU admission, and hospitalization duration. This study will help determine the best fluid resuscitation strategy for treating mild and moderate acute pancreatitis.

Neutrophil-Creatinine Index in Patients with Acute Pancreatitis: Assessment of Severity and Outcome

Acute pancreatitis is a disease that usually has a mild disease course. However, around 20-30% of the patients develop severe complications. Persistent organ failure, with or without the presence of local complications such as (peri-) pancreatic necrosis and secondary infections, is the main determinant for mortality, and these patients are classified as having severe acute pancreatitis according to the revised Atlanta classification . The most widely used classification systems for determining the severity and course of AP are the revised Atlanta classification and the Bedside Index of Severity in Acute Pancreatitis (BISAP). According to the revised Atlanta classification, the severity of AP is graded as mild acute pancreatitis (MAP), moderately severe acute pancreatitis (MSAP), or severe acute pancreatitis (SAP) . In addition to the revised Atlanta classification and BISAP, several other prognostic scoring systems and classifications have been developed to predict the severity of AP. Ranson's criteria, the Acute Physiology and Chronic Health Evaluation (APACHE) II score, the Modified Glasgow Prognostic Score, and the Balthazar index are other commonly used prognostic systems . Most of these scoring systems include multiple determinants or parameters that must be noted 24 to 48 h after hospitalization, and the estimation of the severity of AP is delayed until 48 h after hospitalization. Thus, these scoring systems are of limited use at admission. On the other hand, in view of the complexity of prognostic scoring systems, several studies have been conducted on the role of simple laboratory parameters and indices in predicting the disease severity of AP and mortality . The most widely studied laboratory parameters and indices are the white blood cell count (WBC), neutrophil count, neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), C-reactive protein (CRP), and procalcitonin. These laboratory parameters have also been used as part of several prognostic scoring systems. Nevertheless, none of the laboratory parameters or prognostic scoring systems can predict the severity of AP or MOF with sufficient accuracy . Moreover, it is not easy to predict the course and severity of acute pancreatitis at the first assessment of hospital admission. At the time of admission, most laboratory parameters are insufficient to differentiate mild disease from severe disease, and changes in laboratory parameters over time, including inflammatory markers and parameters related to organ/system dysfunction, provide important clues regarding the course of the disease . On the other hand, there is a need for simple, reliable, widely used parameters at admission for predicting the course of the disease. Sahin (2024) found a new index named the neutrophil-creatinine index (NCI), which was established based on the levels of neutrophil count and creatinine, to predict the severity of AP at admission . It's known that neutrophil infiltration and activation is one of the early events in acute pancreatitis and results in higher neutrophil count values at admission. Similarly, higher creatinine values at admission indicate renal hypoperfusion, which is associated with third-space leakage resulting from a systemic inflammatory state. It was assumed that the NCI may serve as an efficient test to represent the combination of inflammatory response and organ dysfunction .