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

NCT05993429 | Completed

• 1 other identifier: 2023SDU-QILU-3
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma

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

  2023-08-14 to 2027-08-01

Secondary Outcomes (18)

• The incidence of complications

  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

• 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 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

Study Arms (2)

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

Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma

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

Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma

Interventions

The sampling method selected in patients with suspected hilar cholangiocarcinoma DIAGNOSTIC_TEST

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.

ERCP with or without POCS-TB group; EUS-FNA/B group; ERCP with or without POCS-TB group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B or ERCP with or without POCS-TB by experts

You may qualify if:

• ≥ 18 years old;
• Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination

You may not qualify if:

• 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.

Sponsors & Collaborators

• LanZhou University: collaborator
• Beijing Friendship Hospital: collaborator
• Binzhou Medical University: collaborator
• Shandong Provincial Hospital: collaborator
• Shandong Province Third hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Qilu Hospital of Shandong University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

Location

MeSH Terms

Conditions

Klatskin Tumor; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ning Zhong, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 15, 2023
• Study Start: August 14, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 26, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)