跳至主要内容
临床试验/NCT03853447
NCT03853447招募中不适用

Characterization of Fibro-inflammation During Progression From Acute to Chronic Pancreatitis

Copenhagen University Hospital, Hvidovre3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
3
主要终点
Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI)

研究概览

简要总结

Observational prospective study evaluating the developement of chronic pancreatitis based on imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress.

详细描述

Chronic pancreatitis (CP) represents the end-stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent acute pancreatitis (RAP). Due to the irreversible nature of CP, early detection and prevention is key. The study uses state-of-the-art imaging modalities as well as biochemical markers of to evaluate fibrosis progression in patients with pancreatitis.

The included participants have either first time AP, RAP, early CP with preserved pancreatic exocrine and endocrine function or end-stage CP with exocrine insufficiency. Included patients will be followed prospectively for 15 years with advanced MRI and contrast enhanced EUS with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential biomarkers for the progression of disease eventually leading to CP.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with CP (N=50) of any aetiology except gallstone induced CP: CP will be diagnosed based on MANNHEIM criteria .
  • Cohort 2: Patients with their first attack of AP of any aetiology except gallstone induced AP (N=50). The revised Atlanta criteria for acute pancreatitis will be used as diagnostic criteria.
  • Cohort 3: Patients with RAP (N=50) except gallstone induced RAP. RAP is defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria.

排除标准

  • 未提供

结局指标

主要结局

Fibrosis progression on endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI)

时间窗: 15 years

Progression of fibrosis in the pancreas based on either EUS or MRI

次要结局

  • Lean body mass assessed using bioimpedance(15 years)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lise Gluud

Associate Professor

Copenhagen University Hospital, Hvidovre

研究点 (3)

Loading locations...

相似试验