Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis: A Retrospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 主要终点
- global successful rate
研究概览
简要总结
Percutaneous cholecystostomy (PC) is an increasingly performed procedure for acute cholecystitis (AC), safe and less invasive than laparoscopic cholecystectomy, very useful in selected patients (severe comorbidities, not suitable for surgery/general anesthesia,..) The investigators conduct a retrospective observational study. Period: 2016-2021. Inclusion criteria: Patients treated with PC for AC. Tokyo guidelines TG13/18 the investigators algorithm to treat AC.
The characteristics of the sample undergoing Percutaneous Cholecystostomy, main indications, evolution and clinical results were reported in an initial observational study. Subsequently, a retrospective analytical study was designed to compare various cohorts: lithiasic vs alithiasic Acute Cholecystitis, elective vs emergency surgery or management with PC alone.
详细描述
Laparoscopic cholecystectomy (LC) is the gold standard for the treatment of acute cholecystitis (AC). Percutaneous cholecystostomy (PC) is an increasingly performed procedure for AC, safe and less invasive than LC, very useful in selected patients (severe comorbidities, not suitable for surgery/general anesthesia,..).
The theoretical advantages offered by PC are the rapid resolution of sepsis and the optimal preparation of the patient for elective LC . Its main drawback is the possibility of recurrence of AC or other biliary events while awaiting LC.
Thus, many questions about PC remain unanswered: how should the catheter be handled and removed? When is the best time to perform LC? Should cholecystectomy be offered to all patients after PC? Does PC complicate subsequent cholecystectomy? How good is the adherence to the Tokyo Guidelines in real life? To answer these questions, the investigators devised the present study involving patients undergoing PC at the investigators center.
The inclusion criteria were: patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria. The exclusion criteria were: patients undergoing PC for causes other than AC, such as neoplasms, bile duct alterations or non-therapeutic diagnostic purposes; patients who had previously undergone endoscopic drainage.
The characteristics of the sample undergoing PC, main indications, evolution and clinical results were reported in an initial observational study. Subsequently, a retrospective analytical study was designed to compare various cohorts: lithiasic vs alithiasic AC, elective vs emergency surgery or management with PC alone. Patients' main characteristics, associated morbidity (complications according to Clavien-Dindo grade (CD) and 90-day mortality, need for new drain placement, and surgical approach (laparoscopic vs. open) were compared, following the STROCSS 2019 guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria
排除标准
- •Patients undergoing PC for causes other than AC, such as neoplasms, bile duct alterations or non-therapeutic diagnostic purposes;
- •Patients who had previously undergone endoscopic drainage.
结局指标
主要结局
global successful rate
时间窗: through study completion, an average of 1.5 year
the patient did not require a new drain or emergency surgery, did not die due to the infection, and could be discharged from hospital after PC removal
complications rate
时间窗: through study completion, an average of 1.5 year
90-days mortality
时间窗: 90 days
次要结局
- total length of hospitalization during acute episode(through study completion, an average of 1.5 year)
- drainage duration(through study completion, an average of 1.5 year)
- 1-year readmission rate due to biliary complications(1 year)
- cholecystectomy rate(through study completion, an average of 1.5 year)
- The degree of adherence to treatment algorithm of the Tokyo Guidelines 13/18 in the indication of PC(through study completion, an average of 1.5 year)
研究者
Candido Fernando Alcazar-Lopez
Principal Investigator
Hospital General Universitario de Alicante