跳至主要内容
临床试验/NCT04181801
NCT04181801Unknown不适用

Subtotal Cholecystectomy for Complicated Acute Cholecystitis: a Multicenter Prospective Observational Study

Methodist Health System1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年11月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Incidence of post-operative complications and mortality

研究概览

简要总结

We believe that subtotal cholecystectomy is a safe alternative to total cholecystectomy when the complicated gallbladder is encountered, resulting in decreased or equivalent risk of bile duct injury, major vascular injury, postoperative hemorrhage, infectious complications, and mortality. Additionally, we hope to further elucidate the expected outcomes of the varying subtypes of subtotal cholecystectomy in order to determine the safest approach, assuring the lowest need for secondary intervention, recurrent biliary disease, or need for a completion cholecystectomy.

详细描述

The first reported subtotal cholecystectomy occurred in 1955. Additional case reports and studies have been carried out, further defining this terminology as a method of avoiding misidentification injuries of the biliary system or portal vasculature when critical view of safety cannot be safely achieved. Recent data supports the safety of this decision, showing equivalent morbidity rates to total cholecystectomy in a large metanalysis of 1,231 patients. Importantly, only 4 of the 30 included studies were prospective in nature, allowing definition variability and inconsistent reporting of outcomes. Additional reports showed variable data regarding effect on hospital LOS, need for secondary intervention (including endoscopic retrograde cholangiopancreatography (ERCP), percutaneous drainage bilioma, or completion cholecystectomy), infectious complications, biliary or major vascular injury, and mortality. Some studies suggest that while subtotal cholecystectomy is associated with a decreased rate of bile duct injury and a lower conversion to open operation, this comes at the cost of increasing bile leak and recurrent biliary complications. Furthermore, the relatively recent distinction between fenestrating and reconstituting subtypes of subtotal cholecystectomy remain ill-defined in many of these studies, and outcomes between the two modalities remain variable across the literature. There is an obvious need for a head-to-head, prospective comparison between these subtypes to determine the safety and efficacy of the chosen intervention. To determine the impact of these differing techniques for subtotal cholecystectomy (namely reconstituting and fenestrating subtypes) as indicated by Tokyo Criteria (Table 1), for the management of the difficult cholecystectomy on short-term and long-term patient outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Patients ≥ 18 years of age
  • Preoperative definitive diagnosis of acute cholecystitis (Tokyo guideline: Table 1)

排除标准

  • Pregnant patients
  • Prior history of subtotal cholecystectomy
  • Percutaneous cholecystostomy tube in place
  • Preoperative diagnosis other than acute cholecystitis
  • Symptomatic cholelithiasis
  • Gallstone pancreatitis
  • Choledocholithiasis
  • Malignant/benign tumor

结局指标

主要结局

Incidence of post-operative complications and mortality

时间窗: oct 2019 - sept 2021

Incidence of post-operative complications and mortality

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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