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

January 23, 2026 updated by: Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250063
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  1. ≥ 18 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma
Time Frame: 2023-08-14 to 2027-08-01
The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.
2023-08-14 to 2027-08-01

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of complications
Time Frame: 2023-08-14 to 2027-08-01
The incidence of complications after EUS-FNA/B versus ERCP with or without POCS-TB
2023-08-14 to 2027-08-01
The cost-effectiveness ratio
Time Frame: 2023-08-14 to 2027-08-01
The cost-effectiveness ratio of EUS-FNA/B versus ERCP with or without POCS-TB in the diagnosis of hilar cholangiocarcinoma
2023-08-14 to 2027-08-01
The emergency readmission time
Time Frame: 2023-08-14 to 2027-08-01
The emergency readmission time of EUS-FNA versus ERCP with or without POCS-TB
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.
Time Frame: 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.
Time Frame: 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
The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.
Time Frame: 2023-08-14 to 2027-08-01
The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.
2023-08-14 to 2027-08-01
The incidence rate of needle tract metastasis by EUS-FNA/B
Time Frame: 2023-08-14 to 2027-08-01
The incidence rate of needle tract metastasis by EUS-FNA/B
2023-08-14 to 2027-08-01
The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.
Time Frame: 2023-08-14 to 2027-08-01
The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.
2023-08-14 to 2027-08-01
The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.
Time Frame: 2023-08-14 to 2027-08-01
The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.
2023-08-14 to 2027-08-01
Maximum lesion size
Time Frame: 2023-08-14 to 2027-08-01
Maximum lesion size on EUS
2023-08-14 to 2027-08-01
Lesion shape
Time Frame: 2023-08-14 to 2027-08-01
Lesion shape (ovoid-to-round, irregular) on EUS.
2023-08-14 to 2027-08-01
Lesion composition
Time Frame: 2023-08-14 to 2027-08-01
Lesion composition (cystic, partially cystic, solid) on EUS.
2023-08-14 to 2027-08-01
Lesion margin
Time Frame: 2023-08-14 to 2027-08-01
Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.
2023-08-14 to 2027-08-01
Lesion echogenicity
Time Frame: 2023-08-14 to 2027-08-01
Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.
2023-08-14 to 2027-08-01
Lesion heterogeneity
Time Frame: 2023-08-14 to 2027-08-01
Lesion heterogeneity on EUS.
2023-08-14 to 2027-08-01
Lesion growth pattern
Time Frame: 2023-08-14 to 2027-08-01
Lesion growth pattern on EUS.
2023-08-14 to 2027-08-01
Lesion blood flow
Time Frame: 2023-08-14 to 2027-08-01
Lesion blood flow (none, poor, moderate, rich) on EUS.
2023-08-14 to 2027-08-01
Lesion elastography
Time Frame: 2023-08-14 to 2027-08-01
Lesion elastography (stiff, moderate, soft, unvalued) on EUS.
2023-08-14 to 2027-08-01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LanZhou University
Beijing Friendship Hospital
First Affiliated Hospital, Sun Yat-Sen University
Shandong Provincial Hospital
The Third Xiangya Hospital of Central South University
Sir Run Run Shaw Hospital
First Affiliated Hospital of Guangxi Medical University
Binzhou Medical University
Shandong Province Third hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ning Zhong, MD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023SDU-QILU-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholangiocarcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings