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临床试验/NCT04901949
NCT04901949已完成不适用

Comparison of the Severity and Complications of Acute Pancreatitis in Obese and Non-obese Patients According to the Atlanta and Balthazar Scores

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 1,334 人开始时间: 2020年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,334
试验地点
1
主要终点
The course of acute pancreatitis (mild, moderate, and severe) will be evaluated in patients with different body mass index groups.

研究概览

简要总结

In obese (OB) patients, the presence of an increased inflammatory state in the body due to the increase in abdominal adipose tissue and increase in the frequency of gallstones and lipid levels are expected to increase the development of acute pancreatitis (AP). The effect of obesity on the clinical course of acute pancreatitis has much been attracted the attention of researchers.

The aim of this study is to evaluate whether the prevalence and severity of AP, as well as Balthazar tomographic scoring, differs in BMI groups (normal, overweight, obese).

详细描述

Today, the incidence of acute pancreatitis (AP) is gradually increasing. According to the Atlanta criteria, the presence of two of the three findings (characteristic abdominal pain starting from the epigastrium and spreading to the left upper quadrant in a belt manner from there, which is severe enough to bring the patient to the emergency room, amylase and lipase values being 3 of normal, radiological imaging being compatible with AP) is sufficient for the diagnosis. The disease has a mild course of 80% of patients and usually resolves within a week, but the course is severe enough to require intensive care treatment in 15-20% of patients. AP may have local (pseudocyst, abscess, necrosis, vascular thrombosis) and systemic (organ failure; lung, heart, gastrointestinal, and renal) complications.

The frequency of obesity (OB) is also increasing in societies, according to the world health organization (WHO) data, 39% of women aged ≥18 and 39% of men were overweight in 2016 in the world. Overweight and OB are defined as excessive fat accumulation that can impair health, which is an important risk factor for many chronic diseases, including diabetes, cardiovascular disease, and cancer. While once seen only as a problem in high-income countries, overweight and OB are increasing significantly in low- and middle-income countries. Body mass index (BMI) is a simple index commonly used to classify overweight and OB in adults. It is defined by dividing a person's weight by the square of their height (kg/m2). According to WHO, if the BMI is between 25-30 kg/m2, it is considered overweight, if it is ≥30,1 kg/m2, it is considered OB. An increase in the frequency of gallstones, in lipids, and in abdominal adipose tissue in OBs are expected to increase the development of AP as the cytokine and tumor necrosis factor (TNF)-α levels in the body increase. In recent years, the number of publications indicating a relationship between OB and AP frequency has been increasing.

Retrospectively, 1550 patients who followed up at the Gastroenterology Clinic of Bezmialem Vakif University between 10/2010 and 02/2020, aged ≥18 years and diagnosed with AP according to the Atlanta definition criteria were screened. After the exclusion of patients with incomplete data, 1334 patients were included in the study.

Patients' age, gender, smoking/alcohol usage, presence of diabetes/hypertension, and etiologies that cause AP and BMI were recorded.

The patients were divided into 3 groups according to their BMI;

研究设计

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

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

  • Patients with acute pancreatitis diagnosis according to the revised Atlanta criteria.

排除标准

  • Patients who sign a treatment rejection form immediately after admission to the hospital and leave the hospital,
  • Psychiatric patients
  • Patients with very poor general conditions will not be included in the study.

结局指标

主要结局

The course of acute pancreatitis (mild, moderate, and severe) will be evaluated in patients with different body mass index groups.

时间窗: Within a month

The course of acute pancreatitis is defined as mild (no organ insufficiency and local complications), moderate (presence of local complications +/- transient organ insufficiency less than \<48h), and severe (permanent organ insufficiency longer than 48h) according to the revised Atlanta scoring. Body mass index is calculated by dividing the weight of a patient (as a kilogram) by the height (as a square meter). Normal weighted patients form Group 1 (≤24,9 kg/m2), overweighted patients form Group 2 (25-30 kg/m2), and obese patients form Group 3 (≥30,1 kg/m2).

Efficacy of acute pancreatitis tomographic scoring (Balthazar) in different body mass index groups

时间窗: Within a month

Does the course of acute pancreatitis in the body mass index groups (Group 1, 2, and 3) show parallelism with the tomographic scoring? Whether tomographic score is successful or not in different body mass index groups?

次要结局

  • How many times has the patient had an acute pancreatitis attack?(Through study completion, an average of 1 year)
  • Whether interventional procedures such as endosonography or endoscopic retrograde cholangiopancreatography are required due to the patient's disease(Within a month)
  • Hospitalization days of the patients according to body mass index groups?(Within a month)
  • Did the patient lose his life due to AP?(Within a month)
  • Need for intensive care unit hospitalization(Within a month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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