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EUS-FNA/B group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B by experts

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

The appropriate sampling approach was selected as EUS-FNA/B or ERCP with or without POCS-TB based on experts' overall evaluation. This study will compare the histopathological diagnosis of the selected sampling method with the final diagnosis.

The sampling method selected in patients with suspected hilar cholangiocarcinoma

Zhen Li, MD

Ning Zhong, MD

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.

Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma

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

The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.

The incidence of complications after EUS-FNA/B versus ERCP with or without POCS-TB

The cost-effectiveness ratio of EUS-FNA/B versus ERCP with or without POCS-TB in the diagnosis of hilar cholangiocarcinoma

The emergency readmission time of EUS-FNA versus ERCP with or without POCS-TB

The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.

The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.

The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.

The incidence rate of needle tract metastasis by EUS-FNA/B

The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.

The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.

Lesion shape (ovoid-to-round, irregular) on EUS.

Lesion composition (cystic, partially cystic, solid) on EUS.

Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.

Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma	NCT05993429	Klatskin Tumor Cholangiocarcin... Biopsy, Fine-Ne... Endoscopic Retr...	The sampling me...	18 Years - 90 Years	Qilu Hospital of Shandong University
Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma	NCT05993429	Klatskin Tumor Cholangiocarcin... Biopsy, Fine-Ne... Endoscopic Retr...	The sampling me...	18 Years - 90 Years	Qilu Hospital of Shandong University
Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma	NCT05993429	Klatskin Tumor Cholangiocarcin... Biopsy, Fine-Ne... Endoscopic Retr...	The sampling me...	18 Years - 90 Years	Qilu Hospital of Shandong University

Spots Global Cancer Trial Database for the sampling method selected in patients with suspected hilar cholangiocarcinoma