Development and Internal Validation of a Multidimensional Composite Index for Outcome Burden in Acute Cholangitis: A Multicentre Retrospective Cohort Study in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 514
- 试验地点
- 1
研究概览
简要总结
The goal of this retrospective observational study is to construct a composite outcome to measure the success of treatment in patients who are presenting with acute cholangitis (blockage and infection of bile ducts) and undergoing a drainage procedure with different modalities. The study is not intended to test any predetermined hypothesis and does not have any comparison group. The participants' data are collated from retrospective hospital records and analysed for the purpose of the study. All the procedures are in place to ensure the confidentiality of the study participants while collating, analysing and sharing study findings.
详细描述
Study Aim To develop and internally validate a Composite Index that summarizes overall outcome burden in patients with acute cholangitis.
Primary Objective (Index Development)
1. To derive a Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage, that inegrates
- Mortality (30-day and in-hospital)
- Organ support,
- ICU admission and ICU length of stay,
- Complication burden and severity (AGREE and Clavien-Dindo classification as applicable),
- Hospital length of stay,
- 30-day reintervention
- 30-day readmission.
Secondary Objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Hospital admission with definite diagnosis of acute cholangitis meeting TG18 diagnostic criteria
- •TG18 Grade I (Mild) Grade II (moderate) or Grade III (severe) at presentation/admission or prior to drainage.
- •Underwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage).
- •First episode of index BD in case of patients undergoing multiple episodes of index BD as per operational definitions (Technical supplement 1)
- •Planned repeat BD in same admission shall be considered as continuation of the index BD and all the procedural details shall be documented and analysed.
排除标准
- •Pregnant women
- •Missing key outcome data (minimum required: mortality status + ICU admission status + Length of stay)
- •Non-biliary sepsis without evidence of biliary obstruction/infection on review.
- •A patients with past history of BD outside the study setting (As this is akin to second episode of Index BD)
- •Subsequent episodes of Index BD (other than the first index BD episode) among patients with more than one episode of Index BD.
研究组 & 干预措施
Patients with acute cholangitis meeting TG18 diagnostic criteria underwent biliary drainage attempt
干预措施: Biliary drainage (Procedure)
研究者
Hardik Rughwani
Consultant Gastroenterologist
Asian Institute of Gastroenterology, India