Clinical Management Strategies for Patients With Cirrhosis and Esophagogastric Varices Complicated by Early-stage Upper Gastrointestinal Cancer: a Multicenter Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Managing early-stage upper gastrointestinal cancer in patients with liver cirrhosis and esophagogastric varices (EGV) poses substantial clinical challenges. Although endoscopic submucosal dissection (ESD) is an established treatment for these early cancers, its efficacy and safety in this high-risk population are poorly defined. Therefore, this study aims to investigate optimal screening and treatment strategies for early-stage upper gastrointestinal cancer in cirrhotic patients with EGV. Perioperative outcomes were compared between the two groups.
详细描述
Oesophageal and gastric cancers remain leading causes of cancer-related morbidity and mortality worldwide. Early endoscopic screening is crucial, as it significantly improves prognosis. ESD has become the standard minimally invasive treatment for early-stage lesions because it enables en-bloc resection with rapid recovery and favourable cost-effectiveness.
In patients with liver cirrhosis and EGV, however, the management of early-stage upper gastrointestinal cancer is uniquely challenging. First, The detection of early-stage cancer depends on identifying subtle alterations in mucosal coloration and morphology, yet in cirrhotic patients these signs are masked by co-existing varices, portal-hypertensive gastropathy and accompanying mucosal changes, imposcope passage, obscuring inspection and raising the likelihood of missed cancers. Second, underlying coagulopathy and thrombocytopenia in these patients theoretically elevate the risk of procedure-related bleeding, especially when varices are adjacent to or located at the resection area. Presently, clinical guidelines provide no specific guidance for this high-risk population. Existing evidence is limited, derived mostly from small, single-arm studies. To establish a safe and effective standardized management protocol and to evaluate the feasibility of ESD in this setting, we conducted this multicentre, retrospective cohort study to inform clinical decision-making. This study was conducted at 7 tertiary hospitals in China. Consecutive patients who underwent ESD for early-stage upper gastrointestinal cancer between January 2018 and April 2023 were enrolled. Patients were stratified into a cirrhosis group (study group) and a noncirrhosis control group. Inclusion criteria for the study group were: age >18 years; a clinical diagnosis of liver cirrhosis; and endoscopically confirmed EGV. The noncirrhosis group comprised patients over 18 years with early-stage upper gastrointestinal cancer but without cirrhosis, randomly selected from the same pool. Common exclusion criteria were: concomitant end-stage disease of major organs (e.g., active malignancy, heart failure, respiratory failure) or an American Society of Anesthesiologists (ASA) physical status classification ≥ III; previous surgery for cirrhosis, EGV, or other upper gastrointestinal lesions; incomplete clinical records. Preoperative characteristics, demographic data, and perioperative management were compared between groups to inform the development of perioperative strategies for patients with cirrhosis and EGV. Trained investigators extracted demographic, laboratory, perioperative and postoperative outcome data from electronic medical records. Safety indicators included intra/postoperative adverse events, mortality, and ICU transfer. Efficacy indicators were en bloc resection rate, R0 resection rate, procedure time, and resection efficiency.
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
- 否
入选标准
- •The cirrhosis group:
- •Age >18 years;
- •A clinical diagnosis of liver cirrhosis
- •Endoscopically confirmed EGV.
- •The noncirrhosis group:
- •Age > 18 years
- •With early-stage upper gastrointestinal cancer but without cirrhosis
排除标准
- •Concomitant end-stage disease of major organs (e.g., active malignancy, heart failure, respiratory failure) or an American Society of Anesthesiologists (ASA) physical status classification ≥ III
- •Previous surgery for cirrhosis, EGV, or other upper gastrointestinal lesions
- •Incomplete clinical records.
研究组 & 干预措施
cirrhosis group
cirrhotic patients with EGV and early-stage upper gastrointestinal cancer 问 who underwent ESD
noncirrhosis group
Patients who underwent ESD without cirrhosis and EGV
结局指标
主要结局
Mortality
时间窗: Perioperative
Patients who died due to ESD
ICU transfer
时间窗: Perioperative
Transferred to ICU due to ESD
Intraoperative major bleeding
时间窗: Perioperative
Intraoperative major bleeding was defined as active bleeding requiring specific endoscopic hemostasis
en bloc resection rate
时间窗: Perioperative
En bloc resection was complete removal of the lesion in one piece without fragmentation
R0 resection
时间窗: Perioperative
R0 resection was histopathological confirmation of tumour-free lateral and vertical margins
Delayed bleeding
时间窗: Perioperative
Delayed bleeding was defined as any evidence of gastrointestinal hemorrhage
次要结局
- Other intra/postoperative adverse events(Perioperative)
- Procedure time(Perioperative)
- ESD efficiency(Perioperative)
研究者
ChenMingkai
Department of Gastroenterology
Renmin Hospital of Wuhan University
