跳至主要内容
临床试验/NCT06658665
NCT06658665尚未招募不适用

Nomogram for Predicting Postoperative Early Biliary Complication in Adult Patients Following Liver Transplantation: a Retrospective Study

Sun Yat-sen University0 个研究点目标入组 900 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
900
主要终点
Blood Loss

研究概览

简要总结

The goal of this observational study is to develop a nomogram model to predict biliary complications within 90 days in adult patients after liver transplantation. The main questions it aims to answer are:

Can the nomogram predict biliary complications within 90 days in adult patients after liver transplantation? What about the performance of the nomogram? Researchers will compare patients' preoperative variables, intraoperative factors, and postoperative outcomes to see what factors are associated with biliary complications.Subsequently, multivariable logistic regression analysis was conducted to evaluate the factors associated with biliary complications occurring within 90 days post-liver transplantation. Finally, a nomogram was developed.

详细描述

Background: Liver transplantation (LT) is a critical therapeutic intervention for patients with end-stage liver disease or acute liver failure, offering favorable outcomes with survival rates of 76-90% at 1 year and approximately 70% at 5 years . Despite significant advancements in surgical techniques, immunosuppressive protocols, and organ preservation, biliary complications (BCs) remain a substantial cause of morbidity and mortality, frequently necessitating long-term interventions such as endoscopic, percutaneous, or surgical procedures. The incidence of BCs post-LT is estimated to range from 5% to 20%, with most occurring within the first three months postoperatively, although some may present years after LT . Among BCs, the most common are anastomotic strictures (AS), non-anastomotic strictures (NAS), and bile leaks. Treatment approaches include endoscopic techniques, percutaneous transhepatic biliary drainage, and surgical interventions. NAS and bile leaks typically manifest within the first year post-transplant but may arise later, with bile leaks occurring immediately or within weeks following surgery . Early postoperative monitoring and timely management are essential to preventing and addressing these complications.

In adult liver transplantation, several factors contribute to bile duct complications, including biliary ischemia, surgical techniques, infections, and donor characteristics . Among these, insufficient arterial blood supply to the bile ducts is recognized as a key factor likely contributing to the development of biliary complications. Unlike the liver parenchyma, which receives blood from both the portal vein and hepatic artery, the bile ducts depend solely on arterial blood flow. About 60% of the common bile duct's blood comes from the gastroduodenal artery, with the remaining 30-40% from hepatic artery branches. After liver transplantation, blood flow from the gastroduodenal artery is often disrupted, making the hepatic artery's role in supplying the distal bile duct even more critical. This reduced arterial support highlights the significance of maintaining adequate hepatic artery perfusion to prevent bile duct complications.

Ultrasound is essential for monitoring post-liver transplantation biliary complications, providing detailed imaging for early detection of issues like strictures and leaks. Parameters such as arterial resistive index (ARI) and flow velocity are critical for assessing hepatic artery condition and blood supply post-transplantation, offering insights into graft perfusion and viability. These non-invasive metrics are crucial for evaluating hepatic arterial circulation, may provide effective postoperative care and improving patient outcomes.

After liver transplantation, biliary complications most commonly occur during the early postoperative period, particularly within the first three months. More than half of all biliary complications are early complications occurring at the anastomotic site. Hence, early monitoring and intervention are crucial to promptly detect and manage these potential complications, thereby improving patient prognosis and survival rates in clinical settings. However, there is limited research on the risk factors and predict model for 90 days biliary complications after adult liver transplantation. Nomogram is a simple visual graph of statistical prediction model with an easy-to-use graphical interface. Importantly, it could generate personalized predictions, thereby, widely used in risk stratification and personally providing approach to disease management. This study aimed to establish a nomogram model to evaluate patients who underwent LT to help clinicians predict the risk of 90 days biliary complications and provide a more personalized treatment strategy.

Method Patients Data from patients who underwent OLT between 1 January 2016 to 31 December 2021 at the First Affiliated Hospital of Sun Yat-sen University were retrospectively extracted from the electronic medical record system. Exclusion criteria included age <18 years old, multiple organ transplantation, retransplantation, died intraoperatively or within 3 months after LT, and cases with missing important data or over 20% of data missing. Finally, a total of 757 patients were enrolled. This research study was reviewed and approved by the Ethics Committee at Hospital, waiving the requirement for informed consent in alignment with the Declaration of Helsinki. All operations were performed in accordance with the standard procedures by experienced surgical groups in our department.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ①Patients aged ≥ 18 years.
  • ②Patients who underwent their first liver transplantation at Sun Yat-sen University First Affiliated Hospital between January 1, 2016, and December 31, 2021.

排除标准

  • Living donor liver transplantation. ② Split liver transplantation.
  • Multi-organ transplantation. ④ Missing preoperative baseline indicators and postoperative ultrasound examination results.
  • Patients undergoing re-transplantation.

结局指标

主要结局

Blood Loss

时间窗: 1-2 days before surgery

Measured in milliliters (mL).

Cold Ischemic Time

时间窗: intraoperative time

Measured in minutes.

Warm Ischemic Time

时间窗: intraoperative time

Measured in minutes.

Body Mass Index (BMI):

时间窗: 1-2 days before surgery

Calculated as weight (kg) / height (m²).

Surgical Technique

时间窗: Intraoperative time

Type of technique used (orthotopic, piggyback, or ischemia-free liver transplantation).

Weight

时间窗: 1-2 days before surgery

Measured in kilograms.

Height

时间窗: 1-2 days before surgery

Measured in meters.

次要结局

  • Transaminase Levels(24 hours post-surgery.)
  • ICU Stay Duration(24 hours post-surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zepeng lin

resident doctor

Sun Yat-sen University

相似试验

Nomogram for Predicting Biliary Complication | 临床试验