NCT05993429

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Klatskin Tumor
• Cholangiocarcinoma
• Biopsy, Fine-Needle
• Endoscopic Retrograde Cholangiopancreatography

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The sampling method selected in patients with suspected hilar cholangiocarcinoma	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.

Timeline

• Start date: 2023-08-14
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-08-15
• Last updated: 2026-01-26

Locations

1 site across 1 country: China