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临床试验/NCT04907266
NCT04907266已完成不适用

Validation Of Chronic Pancreatitis Prognosis Score (COPPS) in a Tropical Cohort of Chronic Pancreatitis

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
177
试验地点
1
主要终点
Total number of days spent in hospital within 12 months from inclusion

研究概览

简要总结

Clinical course of chronic pancreatitis is still unpredictable, due to the lack of clinical classification. There is no model to assess disease severity or progression or predict patient outcomes. So we need to validate an objective predictive model - Chronic Pancreatitis Prognosis Score (COPPS) for classification, prognostication and management in Chronic Pancreatitis (CP)

详细描述

INTRODUCTION Chronic pancreatitis is an inflammatory disease of the pancreas characterized by abdominal pain, repeated episodes of acute pancreatitis, and fibrotic destruction of the organ, resulting in exocrine and endocrine insufficiency. During the last decade, several reports have provided evidence that repeated attacks of acute pancreatitis may progress to chronic pancreatitis [1].

The disease may present clinically either with an individual symptom or a combination of symptoms associated with loss of pancreatic function. The natural history of chronic pancreatitis is usually characterized by progression of tissue damage and various degrees of exocrine and endocrine pancreatic insufficiency, which will become apparent over time, independent of the underlying etiology, chronic pancreatitis evolves toward the same end stage, i.e., pancreatic fibrosis [2].

The prevalence of CP has been approximated at ~50/100,000 population [3]. The underlying etiologies are multifactorial and among many involve excessive alcohol consumption, smoking, genetic predisposition and autoimmune pancreatitis.

It is general knowledge that the terminal stage of chronic pancreatitis results in a loss of organ function, with the clinical manifestations of maldigestion and diabetes mellitus. However, there is little knowledge of the early structural and functional abnormalities because the current diagnostic imaging procedures are not sensitive enough to visualize them and histology is normally not available in these early stages [4].

Abdominal pain is the most frequent symptom of CP. However, the severity, temporal nature, and natural history of pain is highly variable [5].

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Total number of days spent in hospital within 12 months from inclusion

时间窗: 12 months

Number of days spent in hospital

Total number of hospitalizations (all reasons)

时间窗: 12 months

Number of times patient admitted in hospital

次要结局

  • pancreatitis related no of readmissions(12 months)
  • pancreatitis-related complications(12 months)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kshaunish Das

Professor, Division of Gastroenterology, School of Digestive and Liver Diseases

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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