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临床试验/NCT04312984
NCT04312984已完成不适用

The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis

Manchester University NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年11月30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
30
试验地点
1
主要终点
Pain Relief

研究概览

简要总结

This is a anonymised case note study looking at the long term outcomes of patients with Chronic Pancreatitis on micro nutrient antioxidant treatment.

详细描述

Chronic pancreatitis is the medical term for chronic inflammation of the pancreas. This illness is associated with long-term abdominal pain. In the 1980s it was proposed that chronic pancreatitis was due to a deficiency of protective "antioxidants" in the pancreas and on this basis antioxidant therapy was introduced. This therapy was highly controversial until a large randomised trial of antioxidant therapy in chronic pancreatitis, undertaken in Manchester showed that 6 months intervention with antioxidant therapy was not associated with any change in pain score or improvement in quality of life. Antioxidant therapy is no longer used in modern day pancreatic practice.

However, as with any study, the randomised trial raised some specific questions.

First, does treatment for more than 6 months provide benefit? Second, are there disease sub-types of chronic pancreatitis where antioxidant therapy may benefit?

Given the lack of contemporary use of antioxidant therapy, this question cannot be answered in a prospective study. However, the case records of the Manchester Royal Infirmary contain information on antioxidant treatment in patients who received this therapy over a prolonged period.

Thus the aim of the present study is to review the case notes of patients given a discharge code from the Manchester Royal Infirmary of chronic pancreatitis during the period 1st January 1990 to 1st January 1998 in order to assess whether there is a record of improvement in outcome. Only the case notes will be reviewed and patients will be given an opportunity to opt out.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Chronic Pancreatitis treated with Long term anti-oxidants

排除标准

  • Cancer, On trials

结局指标

主要结局

Pain Relief

时间窗: 10 years

Insulin Dependence

时间窗: 10 years

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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