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临床试验/NCT06124989
NCT06124989尚未招募不适用

A Novel Machine Learning Model for the Prediction of Relapse of Acute Biliary Pancreatitis (Machine learnINg for the rElapse Risk eValuation in Acute Biliary Pancreatitis - MINERVA)

University of Cagliari1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
430
试验地点
1
主要终点
Number of patients with recurrence of biliary acute pancreatitis.

研究概览

简要总结

The MINERVA (Machine learnINg for the rElapse Risk eValuation in Acute biliary pancreatitis) project stems from the need in the clinical practice of taking an operational decision in patients that are admitted to the hospital with a diagnosis of acute biliary pancreatitis. In particular, the MINERVA prospective cohort study aims to develop a predictive score that allows to assess the risk of hospital readmission for patients diagnosed with mild biliary acute pancreatitis using Machine Learning and artificial intelligence.

The objectives of the MINERVA study are to:

  1. Propose a novel methodology for the assessment of the risk of relapse in patients with mild biliary acute pancreatitis who did not undergo early cholecystectomy (within 3 to 7 days from hospital admission);
  2. Propose a Machine Learning predictive model using a Deep Learning architecture applied to easily collectable data;
  3. Validate the MINERVA score on an extensive, multicentric, prospective cohort;
  4. Allow national and international clinicians, medical staff, researchers and the general audience to freely and easily access the MINERVA score computation and use it in their daily clinical practice.

The MINERVA score model will be developed on a retrospective cohort of patients (MANCTRA-1, already registered in ClinicalTrials.gov) and will be validated on a novel prospective multicentric cohort. After validation, the MINERVA score will be free and easy to compute instantly for all medical staff; it will be accessible at any time on the MINERVA website and web app, and will provide an immediate and reliable result that can be a clear indication for the best treatment pathway for the clinician and for the patient.

详细描述

Acute pancreatitis is the most common pancreatic disease, with a global incidence of 34 cases per 100,000 individuals. This disease counts more than 1.5 million new patients per year worldwide, with a mortality that approaches 1%. Mild biliary acute pancreatitis patients, when admitted to the hospital, can be treated with index, early cholecystectomy (within 3 to 7 days from the acute episode) or conservatively. While conservative treatment can be resolutive, up to 35% of these patients have a relapse within 30 days, and require emergency surgery in a significantly worse overall patient condition, reducing the chances of success. Other than that, relapse dramatically increases the chances of chronic pancreatitis, pancreatic cancer, postoperative complications and overall mortality. Relapse episodes have also an economic impact on healthcare facilities, as a second and longer hospital admission per patient increases the overall medical cost per patient by at least 100%. So far, however, there are no standardised methods to predict relapse of biliary acute pancreatitis in patients who did not undergo early cholecystectomy after the first episode of mild biliary acute pancreatitis.

The MINERVA (Machine learnINg for the rElapse Risk eValuation in Acute biliary pancreatitis) project stems from the need in the clinical practice of taking an operational decision in patients that are admitted to the hospital with a diagnosis of mild acute biliary pancreatitis.

The MINERVA project aims to reach the following objectives and results:

  1. Propose a novel methodology for the assessment of the risk of relapse in patients with mild biliary acute pancreatitis who did not undergo early cholecystectomy after the first episode of mild biliary acute pancreatitis;
  2. Propose a Machine Learning predictive model using a Deep Learning architecture applied to data easy to collect from patients;
  3. Validate the MINERVA score on an extensive, multicentric, prospective cohort;
  4. Allow national and international clinicians, medical staff, researchers and the general audience to freely and easily access the MINERVA score computation and use it in their daily clinical practice.

The MINERVA score will provide the clinicians with a validated and standardized assessment of relapse risk that takes into account the personal history, demographic data and laboratory characteristics of each patient. The MINERVA score will be free and easy to compute instantly for all medical staff; it will be accessible at any time on the MINERVA website and web app, and will provide an immediate and reliable result that can be a clear indication for the best treatment pathway for the clinician and for the patient.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥ 18 years old)
  • Clinical diagnosis of mild biliary acute pancreatitis (according to the Revised Atlanta Classification)
  • Not submitted to cholecystectomy or ERCP/ES (Endoscopic Retrograde CholangioPancreatography/Endoscopic Sphyncterotomy) during the same hospital admission

排除标准

  • Acute pancreatitis of etiology other than gallstones;
  • Moderately-severe pancreatitis;
  • Severe pancreatitis;
  • Presence of pancreatic necrosis;
  • Pregnant patients;
  • Patients not able to sign the informed consent to take part in the study.

结局指标

主要结局

Number of patients with recurrence of biliary acute pancreatitis.

时间窗: 30-day, 60-day, 90-day, 1-year

The number of patients with recurrence of biliary acute pancreatitis: prediction of risk relapse of acute biliary pancreatitis in patients after a first episode of mild biliary acute pancreatitis (according to the 2012 Revised Atlanta Classification) not submitted to early (within three to seven days from the acute episode) cholecystectomy. This outcome will be reached by the development and validation of a novel risk score.

次要结局

  • Accuracy of the MINERVA model.(30-day, 60-day, 90-day, 1-year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauro Podda

Prof.

University of Cagliari

研究点 (1)

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