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临床试验/NCT06573021
NCT06573021已完成不适用

The Role of Fluorescent Cholangiography to Improve Operative Safety in Different Severity Degree of Acute Cholecystitis During Emergency Laparoscopic Cholecystectomy.

University Hospital of Ferrara1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
1
主要终点
Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy

研究概览

简要总结

Currently, there is limited scientific evidence regarding the effectiveness of fluorescent cholangiography in emergency cholecystectomy for acute cholecystitis. The primary aim of this study was to assess the efficacy of near-infrared fluorescent cholangiography to detect extrahepatic biliary anatomy in different severity degrees of acute cholecystitis.

详细描述

The study aims to to evaluate the efficacy of near-infrared fluorescent cholangiography for real-time visualization of the extrahepatic biliary tree (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct and any accessory or aberrant ducts) in emergency laparoscopic cholecystectomy before and after hepatocystic triangle dissection and in different degrees of severity of acute cholecystitis according to the American Association of Surgery for Trauma (AAST) classification, specifically distinguishing between non-gangrenous (grade I) and gangrenous or complicated (grades II-V) forms. For intra-operative fluorescent cholangiography, 2.5 mg indocyanine green (ICG) was administered intravenously 45-60 min prior to surgery, according to the recent guidelines from the International Society for Fluorescence Guided Surgery. All the operations were performed by the same team of surgeons. Near-infrared fluorescent cholangiography was performed by using Stryker's fluorescence imaging system (Stryker, Portage, Miami, USA). Near-infrared fluorescent cholangiography was performed at three defined time point during laparoscopic cholecystectomy: (i) following exposure of Calot's triangle, prior to any dissection; (ii) after partial dissection of Calot's triangle; (iii) after complete dissection of Calot's triangle, according to the "Critical View of Safety" method.

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

入选标准

  • patients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised TG18 who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms;
  • patients with ASA score of 1-3;

排除标准

  • patients with a known allergy to indocyanine green;
  • ASA score 4-5;
  • patients deemed non-operable via laparoscopic approach due to high cardio-respiratory risk;
  • previous surgical interventions on the biliary tract;
  • history of liver cirrhosis or severe liver disease;
  • ongoing pregnancy or breastfeeding.

研究组 & 干预措施

Patients with a clinical and radiological diagnosis of acute cholecystitis

Patients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised Tokyo guidelines who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms and patients with American Society of Anesthesiologists (ASA) score of 0-3. Near-infrared fluorescent cholangiography was performed at three time points during laparoscopic cholecystectomy: (i) following exposure of Calot's triangle, prior to any dissection; (ii) after partial dissection of Calot's triangle; (iii) after complete dissection of Calot's triangle.

干预措施: Near-infrared fluorescent cholangiography (Drug)

结局指标

主要结局

Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy

时间窗: From start of surgery to the end of Calot's triangle dissection

The primary aim was to analyze the correct visualization by fluorescence of extrahepatic bile ducts (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct, and any accessory or aberrant ducts) before and after Calot's dissection in different grades of severity of acute cholecystitis according to the AAST classification, particularly distinguishing non-gangrenous forms (grade I) from gangrenous and complicated forms (grades II-V).

次要结局

  • The length of stay in emergency cholecystectomy by fluorescence(perioperatively)
  • Conversion rate in emergency cholecystectomy by fluorescence(perioperatively)
  • The bail-out procedures rate in emergency cholecystectomy by fluorescence(perioperatively)
  • The rate of bile duct injuries in emergency cholecystectomy by fluorescence(perioperatively)
  • The duration of surgery in emergency cholecystectomy by fluorescence(perioperatively)
  • Analysis of post-operative complications in emergency cholecystectomy by fluorescence(up to 30 days)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Feo

Principal investigator

University Hospital of Ferrara

研究点 (1)

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