Diagnostic Efficacy of Endoscopic Ultrasound-guided Fine-needle Aspiration/Biopsy Versus Endoscopic Retrograde Cholangiopancreatography With or Without Peroral Cholangioscopy Targeted Biopsy for Suspected Hilar Cholangiocarcinoma: an Open Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma
研究概览
简要总结
This is an observational study with a prospective cohort design. This study enrolled patients with suspected hilar cholangiocarcinoma on imaging. This study aims to evaluate the histopathological diagnostic efficacy of endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) and endoscopic retrograde cholangiopancreatography (ERCP) with or without peroral cholangioscopy targeted biopsy (POCS-TB) in patients with suspected hilar cholangiocarcinoma. In addition, the incidence of complications was compared between the EUS-FNA/B and ERCP with or without POCS-TB. The impact of the histopathological diagnosis on survival outcomes in patients with suspected hilar cholangiocarcinoma was evaluated.
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 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old;
- •Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination
排除标准
- •Patients with a definite diagnosis of cholangiocarcinoma by imaging (enhanced CT, MRI, or MRCP) and surgical candidacy within 3 months;
- •Patients scheduled for liver transplantation;
- •Patients with previous gastroduodenal diversion or biliary surgery;
- •Patients with hilar bile duct stenosis caused by tumor or lesion outside the bile duct;
- •Pregnant or lactating women;
- •Patients who cannot tolerate intravenous general anesthesia due to various reasons;
- •Patients with severe coagulation dysfunction, or patients who cannot stop antiplatelet/anticoagulant therapy for a short time and are unsuitable for low molecular weight heparin replacement therapy;
- •Patients who refused to sign informed consent.
研究组 & 干预措施
EUS-FNA/B group; ERCP with or without POCS-TB group
EUS-FNA/B group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B by experts
干预措施: The sampling method selected in patients with suspected hilar cholangiocarcinoma (Diagnostic Test)
ERCP with or without POCS-TB group
ERCP with or without POCS-TB group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by ERCP with or without POCS-TB by experts
干预措施: The sampling method selected in patients with suspected hilar cholangiocarcinoma (Diagnostic Test)
结局指标
主要结局
The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma
时间窗: 2023-08-14 to 2027-08-01
The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.
次要结局
- Lesion composition(2023-08-14 to 2027-08-01)
- Lesion margin(2023-08-14 to 2027-08-01)
- Lesion echogenicity(2023-08-14 to 2027-08-01)
- The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.(2023-08-14 to 2027-08-01)
- The incidence rate of needle tract metastasis by EUS-FNA/B(2023-08-14 to 2027-08-01)
- Lesion growth pattern(2023-08-14 to 2027-08-01)
- Lesion blood flow(2023-08-14 to 2027-08-01)
- Lesion elastography(2023-08-14 to 2027-08-01)
- The cost-effectiveness ratio(2023-08-14 to 2027-08-01)
- The emergency readmission time(2023-08-14 to 2027-08-01)
- Maximum lesion size(2023-08-14 to 2027-08-01)
- Lesion shape(2023-08-14 to 2027-08-01)
- Lesion heterogeneity(2023-08-14 to 2027-08-01)
- The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.(2023-08-14 to 2027-08-01)
- The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.(2023-08-14 to 2027-08-01)
- The incidence of complications(2023-08-14 to 2027-08-01)
- The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.(2023-08-14 to 2027-08-01)
- The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.(2023-08-14 to 2027-08-01)