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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-14

Study Completion Date

2027-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Klatskin Tumor Cholangiocarcinoma Biopsy, Fine-Needle Endoscopic Retrograde Cholangiopancreatography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

The sampling method selected in patients with suspected hilar cholangiocarcinoma

Intervention Type 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

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 sampling method selected in patients with suspected hilar cholangiocarcinoma

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 18-90 years old;
2. Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination

Exclusion Criteria

1. Patients with a definite diagnosis of cholangiocarcinoma by imaging (enhanced CT, MRI, or MRCP) and surgical candidacy within 3 months;
2. Patients scheduled for liver transplantation;
3. patients with previous gastroduodenal diversion or biliary surgery;
4. Patients with hilar bile duct stenosis caused by tumor or lesion outside the bile duct;
5. Pregnant or lactating women;
6. Patients who cannot tolerate intravenous general anesthesia due to various reasons;
7. 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;
8. Patients who refused to sign informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No