Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,183
- 试验地点
- 1
- 主要终点
- Number of patients with pancreatic necrosis as assessed by their clinical course.
研究概览
简要总结
This study is an ancillary of APPRENTICE. This will be the international based study.
详细描述
This study is an ancillary of APPRENTICE. This will be the international based study. The initial study design with discussions about the different variables to be included into our prospective database started during 2014 PancreasFest held in Pittsburgh, PA in late July 2014 under the sponsorship of Collaborative Alliance for Pancreatic Education and Research (CAPER). Following this, a datasheet with variables was created, distributed through the initial participants, and further suggestions and edits were made. We now plan to move ahead with a web based seminar. All previous participants, as well as new investigators/centers that have shown interest in participating throughout the world will be invited.University of Pittsburgh will be responsible for collecting all required regulatory documents from other sites. Developing templates for questionnaires and other data collection forms. Will train approved sites on procedures. The coordinating center will be the recipient of de-identified data and will not be involved in the collection of data.
Note that copies of training records, licenses, certificates should be maintained in the study regulatory binder and are subject to audit by the Research Conduct and Compliance Office (RCCO).
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
- 否
入选标准
- •The diagnosis of AP based upon presence of two out of the three following criteria:
- •Abdominal pain typical to AP
- •Serum amylase or lipase levels more than three times the upper limit of normal
- •Imaging findings suggestive of AP
- •Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).
排除标准
- •Age under 18 years
- •Unwilling to provide consent by patient or his/her proxy
- •Presence of pancreatic cancer
- •Presence of chronic pancreatitis
- •Occurrence of AP following a multiple trauma episode
- •Having history of organ transplant
- •Presence of any cancer which required chemotherapy or radiation therapy in the past year.
结局指标
主要结局
Number of patients with pancreatic necrosis as assessed by their clinical course.
时间窗: 12 months
Evaluation of the existing risks, predictive scores, and markers of severe disease.
Number of patients with persistent organ failure as assessed by their clinical course.
时间窗: 12 months
Evaluation of the current management and outcomes of acute pancreatitis around the world.
次要结局
未报告次要终点
研究者
Georgios Papachristou
Professor of Medicine
University of Pittsburgh
