跳至主要内容
临床试验/NCT07714850
NCT07714850尚未招募不适用

Early Upper Gastrointestinal Endoscopic Findings as Predictors of Disease Course and Severity in Acute Pancreatitis: A Prospective Observational Cohort Study

Jan Kochanowski University0 个研究点目标入组 200 人开始时间: 2026年9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
发起方
入组人数
200
主要终点
Number and Percentage of Participants With Moderately Severe or Severe Acute Pancreatitis

研究概览

简要总结

This is a prospective observational cohort study designed to evaluate early upper gastrointestinal endoscopic findings in adult patients hospitalized with acute pancreatitis. The study aims to determine whether gastric and duodenal mucosal abnormalities detected during early hospitalization are associated with the severity and clinical course of acute pancreatitis.

Adult patients diagnosed with acute pancreatitis according to the revised Atlanta criteria will be enrolled after providing informed consent. Upper gastrointestinal endoscopy will be performed within 24-48 hours from hospital admission. In patients with moderately severe or severe acute pancreatitis, a follow-up endoscopy may be performed before discharge. Clinical, laboratory, imaging, microbiological, and endoscopic data will be collected prospectively during the index hospitalization.

The primary objective is to assess the association between early endoscopic mucosal abnormalities and acute pancreatitis severity according to the revised Atlanta classification. Secondary objectives include evaluation of the relationship between endoscopic findings and organ failure, local or systemic complications, inflammatory markers, nutritional tolerance, length of hospital stay, need for invasive interventions, and in-hospital mortality.

The study has received a positive opinion from the Bioethics Committee of Jan Kochanowski University in Kielce, Collegium Medicum, resolution no. 27/2026 dated May 20, 2026.

详细描述

Acute pancreatitis is one of the most common acute gastrointestinal conditions requiring hospital admission and is associated with a highly variable clinical course. Although most patients develop a mild and self-limiting form of the disease, a clinically important proportion progress to moderately severe or severe acute pancreatitis, with local complications, systemic inflammatory response, organ failure, prolonged hospitalization, need for invasive interventions, and increased mortality. Early identification of patients at risk of an unfavorable course remains a major clinical challenge. Existing prognostic systems and laboratory markers are useful, but they do not fully capture all clinically relevant determinants of disease progression, particularly those related to early upper gastrointestinal mucosal injury, gastric and duodenal involvement, and local inflammatory response in the upper gastrointestinal tract.

The revised Atlanta classification provides a widely accepted framework for the diagnosis and severity assessment of acute pancreatitis. According to this classification, acute pancreatitis is diagnosed when at least two of the following three criteria are present: typical abdominal pain, serum amylase or lipase activity at least three times the upper limit of normal, and imaging findings consistent with acute pancreatitis. Disease severity is classified as mild, moderately severe, or severe. Mild acute pancreatitis is characterized by the absence of organ failure and local or systemic complications. Moderately severe acute pancreatitis is associated with transient organ failure lasting less than 48 hours and/or local or systemic complications without persistent organ failure. Severe acute pancreatitis is defined by persistent organ failure lasting longer than 48 hours, which may involve one or multiple organ systems.

Despite this classification, early prediction of clinical course remains imperfect. Laboratory parameters such as C-reactive protein, white blood cell count, blood urea nitrogen, creatinine, hematocrit, procalcitonin, and biochemical markers of cholestasis may be associated with severity, but their predictive performance varies. Radiological evaluation, particularly contrast-enhanced computed tomography, plays a key role in detecting pancreatic necrosis and local complications; however, early computed tomography may underestimate evolving changes, and the optimal timing for imaging is usually several days after symptom onset or admission. Clinical scores are available, but they can be complex, may require repeated measurements, and may not sufficiently reflect local upper gastrointestinal effects of the disease.

Upper gastrointestinal symptoms are common in acute pancreatitis. Patients frequently present with nausea, vomiting, epigastric pain, feeding intolerance, ileus, gastroesophageal reflux symptoms, or signs of gastric outlet dysfunction. The stomach and duodenum are anatomically close to the pancreas and may be affected by inflammatory edema, local vascular disturbances, impaired motility, stress-related mucosal injury, duodenal compression, and systemic inflammatory changes. Endoscopic abnormalities such as gastritis, duodenitis, erosions, ulcerations, mucosal edema, hemorrhagic lesions, bile reflux, esophagitis, or signs of impaired gastric emptying may therefore reflect both local and systemic consequences of acute pancreatitis. However, early upper gastrointestinal endoscopy is not routinely performed in all patients with acute pancreatitis, and the prognostic significance of early endoscopic mucosal changes remains insufficiently defined.

Preliminary retrospective observations from the study center suggest that upper gastrointestinal mucosal abnormalities are frequent in patients hospitalized with acute pancreatitis and may be associated with disease severity, inflammatory burden, Helicobacter pylori status, and the subsequent clinical course. These observations provide the rationale for a prospective study designed to systematically evaluate early endoscopic findings in a predefined cohort of adult patients with acute pancreatitis. A prospective design will allow standardized timing of endoscopy, uniform collection of clinical and laboratory data, systematic assessment of disease severity, and evaluation of the relationship between mucosal injury and clinically meaningful outcomes.

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

  • Age 18 years or older.
  • Diagnosis of acute pancreatitis according to the revised Atlanta criteria, defined by the presence of at least two of the following three features:
  • typical abdominal pain consistent with acute pancreatitis; serum amylase and/or lipase activity at least three times the upper limit of normal; imaging findings consistent with acute pancreatitis.
  • Hospital admission due to acute pancreatitis to the study center.
  • Admission during the early phase of acute pancreatitis, allowing planned upper gastrointestinal endoscopy within 24-48 hours from hospital admission.
  • Ability to undergo diagnostic upper gastrointestinal endoscopy according to the investigator's and treating physician's assessment.
  • Ability to provide written informed consent before enrollment and before any study-specific procedure.

排除标准

  • Age below 18 years.
  • Lack of written informed consent.
  • Inability to provide informed consent before enrollment.
  • Clinical condition precluding safe diagnostic upper gastrointestinal endoscopy, including hemodynamic instability, severe respiratory failure, or other unstable life-threatening condition.
  • Need for emergency therapeutic upper gastrointestinal endoscopy before planned study endoscopy, for example due to active upper gastrointestinal bleeding.
  • Known or suspected gastrointestinal perforation.
  • Previous gastric or duodenal surgery significantly altering upper gastrointestinal anatomy and preventing reliable assessment of gastric or duodenal mucosa.
  • Known advanced upper gastrointestinal malignancy affecting the stomach or duodenum.
  • Pregnancy.
  • Contraindication to upper gastrointestinal endoscopy or sedation according to the treating physician's or investigator's assessment.
  • Any condition that, in the investigator's opinion, would make participation unsafe or would prevent completion of study procedures.

结局指标

主要结局

Number and Percentage of Participants With Moderately Severe or Severe Acute Pancreatitis

时间窗: During index hospitalization, from admission to hospital discharge, up to 30 days

Description: Acute pancreatitis severity will be assessed according to the revised Atlanta classification during the index hospitalization. Participants will be classified as having mild, moderately severe, or severe acute pancreatitis. The primary outcome measure will be the number and percentage of participants who develop moderately severe or severe acute pancreatitis. Moderately severe acute pancreatitis is defined as transient organ failure lasting less than 48 hours and/or local or systemic complications without persistent organ failure. Severe acute pancreatitis is defined as persistent organ failure lasting more than 48 hours.

Percentage of Participants With Moderately Severe or Severe Acute Pancreatitis

时间窗: During index hospitalization, from admission to hospital discharge, up to 30 days

Acute pancreatitis severity will be assessed according to the revised Atlanta classification during the index hospitalization. Participants will be classified as having mild, moderately severe, or severe acute pancreatitis. The primary outcome measure will be the percentage of participants who develop moderately severe or severe acute pancreatitis. Moderately severe acute pancreatitis is defined as transient organ failure lasting less than 48 hours and/or local or systemic complications without persistent organ failure. Severe acute pancreatitis is defined as persistent organ failure lasting more than 48 hours.

次要结局

  • Number and Percentage of Participants With Early Upper Gastrointestinal Mucosal Abnormalities(Within 24-48 hours from hospital admission)
  • Percentage of Participants With Early Upper Gastrointestinal Mucosal Abnormalities(Within 24-48 hours from hospital admission)

研究者

发起方
Jan Kochanowski University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Łukasz Nawacki

PhD habilitated

Jan Kochanowski University

相似试验