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临床试验/NCT02048267
NCT02048267已完成不适用

A Prospective Study of Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic 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 24 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Quality of life

研究概览

简要总结

Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic chronic pancreatitis such as analgesic medication, inhibition of gastric acid production, enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not available in literature.

Although it is well known that pain is the main symptom of chronic pancreatitis, it has until now been assessed in very common and varying categories. Pain, however, is only one aspect of the large variety of sensitive facets of daily life. In addition to an improvement in pain symptoms and the preservation of pancreatic exocrine and endocrine function and other parameters, occupational rehabilitation of these mostly young patients and quality of life also should be considered in the evaluation of surgical outcome in alcoholic and non-alcoholic chronic pancreatitis.

In this prospective study, we intend to find out if there are any differences in the surgical outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic pancreatitis.We also plan to see if there are differences in the histopathology in these two disease settings.

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
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of chronic pancreatitis confirmed by at least 2 of the following:
  • Typical Chronic epigastric abdominal pain
  • Elevation of serum Amylase>3 times upper limit normal or
  • Fecal elastase less than 200ug/g stool.
  • Confirmatory findings on cross-sectional imaging:
  • Changes in size, shape and contour of pancreas
  • Dilatation of main pancreatic duct
  • Calcification
  • Pancreatic duct stricture
  • Patients who fulfill the criteria for surgical intervention

排除标准

  • Not agreeing for surgical management
  • On going acute pancreatitis
  • Postop alcohol intake
  • Pregnancy.
  • Chronic pancreatitis with Malignancy

结局指标

主要结局

Quality of life

时间窗: Within first 6 months from the time of surgery

Differences in extent of parenchymal fibrosis, inflammation and ductal obstruction of alcoholic and non alcoholic chronic pancreatitis

时间窗: Two weeks after surgery

次要结局

  • HbA1C,Fasting insulin and C-peptide levels(Within first 6 months after surgery)
  • Pain relief(Within first 6 months after surgery)
  • Fecal elastase levels(Within first 6 months after surgery)

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

Rajesh Gupta

Additional Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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