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

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

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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Binzhou Medical University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Shandong Province Third hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Qilu Hospital of Shandong University

  lead OTHER

Principal Investigators

• Ning Zhong, MD · Qilu Hospital of Shandong University

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-14

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations