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临床试验/NCT06549881
NCT06549881已完成不适用

Emergency Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence: a Single Center Experience

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
incidence of postoperative complications

研究概览

简要总结

A consecutive case series report to share our experience in surgical outcome of patients who underwent emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. The patients were recruited in PUMCH emergency department from 2023 to 2024.

详细描述

Acute calculous cholecystitis, typically occurs in patients with gallstones, accounts for 90 to 95% of acute cholecystitis. Emergent laparscopic cholecystectomy (ELC) is the major treatment option. Traditionally, the time frame for ELC is generally considered to be within 72 hours from the onset of symptoms. However, with the development of surgical techniques, nowadays, ELC is also considered for patients with symptoms onset within 10 days and hospital stays within 7 days. The determination of the time frame for ELC in acute cholecystitis is primarily based on the risk of complications occurring. Comparing to delayed laparscopic cholecystectomy (DLC), ELC has advantages in post-operative complications in patients with symptoms onset within 72 hours. Post-operative complications for both DLC and ELC include bile leaks, intestinal obstruction, ascites, intraperitoneal hemorrhage, would bleeding and hematoma, wound infection and calculus remaining. Most of them associate with intraoperative procedures. Laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence, comparing to conventional laparscopic procedures, can help the surgeons to identify bile tracts and therefore may reduce the complications. Therefore, we conduct this case series report to share our single center experience of surgical outcomes and economic effectiveness of laparoscopic cholecystectomy guided by ICG.

The surgical outcomes are evaluated by both intraoperative events and postoperative events. Intraoperative events contain the following items: (1) incidence of intraoperative accidental bile tract injury, (2) intraoperative bleeding (volume), (3) operation time. Postoperative events contain the following items: (1) incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay, (2) duration of postoperative hospital stay. The economic effectiveness is evaluated by cost of hospital stay.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All of the hospitalized patients of underwent emergent laparscopic cholecystectomy guided by ICG fluorescence by the emergent surgeon team from 1st August 2023 to 1st Feburary 2024 in the department of Emergency in Peking Union Medical College Hospital

排除标准

  • Patients with incomplete medical records. Patients have other emergent conditions which warrant other emergent operations or major treatment simultaneously besides ELC.

结局指标

主要结局

incidence of postoperative complications

时间窗: within 1 month after discharge

incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay

incidence of intraoperative accidental bile tract injury

时间窗: within 1 month after after discharge

The primary outcome is incidence of intraoperative accidental injury involving the bile tract in emergent laparscopic cholecystectomy guided by ICG fluorescence. The injury manifests as biliary obstruction, biliary leak, or biliary stricture. Medical records will be reviewed to identify an intraoperative bile tract injury event.

次要结局

  • duration of postoperative hospital stay(within 1 month after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiaofei Liu

Clinical Associate professor

Peking Union Medical College Hospital

研究点 (1)

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