Klatskin TumorNCT05993429
Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma
An observational study of Klatskin Tumor and Cholangiocarcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Klatskin Tumor, Cholangiocarcinoma, Biopsy, Fine-Needle
- What is being tested?
- The sampling method selected in patients with suspected hilar cholangiocarcinoma
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- ≥ 18 years old;
- Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Klatskin Tumor, Cholangiocarcinoma, Biopsy, Fine-Needle, Endoscopic Retrograde Cholangiopancreatography
- Being tested
- The sampling method selected in patients with suspected hilar cholangiocarcinoma
- Medical subject headings
- Klatskin Tumor, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The sampling method selected in patients with suspected hilar cholangiocarcinomaDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2023-08-14 to 2027-08-01
Secondary outcomes (18)
The incidence of complications
The incidence of complications after EUS-FNA/B versus ERCP with or without POCS-TB
Measured: 2023-08-14 to 2027-08-01
The cost-effectiveness ratio
The cost-effectiveness ratio of EUS-FNA/B versus ERCP with or without POCS-TB in the diagnosis of hilar cholangiocarcinoma
Measured: 2023-08-14 to 2027-08-01
The emergency readmission time
The emergency readmission time of EUS-FNA versus ERCP with or without POCS-TB
Measured: 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.
The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.
Measured: 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.
The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.
Measured: 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.
The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.
Measured: 2023-08-14 to 2027-08-01
The incidence rate of needle tract metastasis by EUS-FNA/B
The incidence rate of needle tract metastasis by EUS-FNA/B
Measured: 2023-08-14 to 2027-08-01
The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.
The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.
Measured: 2023-08-14 to 2027-08-01
The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.
The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.
Measured: 2023-08-14 to 2027-08-01
Maximum lesion size
Maximum lesion size on EUS
Measured: 2023-08-14 to 2027-08-01
Lesion shape
Lesion shape (ovoid-to-round, irregular) on EUS.
Measured: 2023-08-14 to 2027-08-01
Lesion composition
Lesion composition (cystic, partially cystic, solid) on EUS.
Measured: 2023-08-14 to 2027-08-01
Lesion margin
Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.
Measured: 2023-08-14 to 2027-08-01
Lesion echogenicity
Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.
Measured: 2023-08-14 to 2027-08-01
Lesion heterogeneity
Lesion heterogeneity on EUS.
Measured: 2023-08-14 to 2027-08-01
Lesion growth pattern
Lesion growth pattern on EUS.
Measured: 2023-08-14 to 2027-08-01
Lesion blood flow
Lesion blood flow (none, poor, moderate, rich) on EUS.
Measured: 2023-08-14 to 2027-08-01
Lesion elastography
Lesion elastography (stiff, moderate, soft, unvalued) on EUS.
Measured: 2023-08-14 to 2027-08-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start14 Aug 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Klatskin TumorStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, LanZhou University, Beijing Friendship Hospital, Binzhou Medical University, Shandong Provincial Hospital, Shandong Province Third hospital, Sir Run Run Shaw Hospital, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Ning Zhong, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993429
- Sponsor's protocol ID
- 2023SDU-QILU-3
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05993429
- Acronym / sponsor ID
- 2023SDU-QILU-3
- Conditions
- Klatskin Tumor, Cholangiocarcinoma, Biopsy, Fine-Needle, Endoscopic Retrograde Cholangiopancreatography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, LanZhou University, Beijing Friendship Hospital, Binzhou Medical University, Shandong Provincial Hospital, Shandong Province Third hospital, Sir Run Run Shaw Hospital, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA/B group; ERCP with or without POCS-TB group | – | Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinomaEUS-FNA/B group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B by experts |
| ERCP with or without POCS-TB group | – | Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinomaERCP 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- ≥ 18 years old;
- Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The sampling method selected in patients with suspected hilar cholangiocarcinomaThe 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. | Diagnostic test | ERCP with or without POCS-TB group, EUS-FNA/B group; ERCP with or without POCS-TB group |
Primary outcome
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.
18 secondary outcomes
The incidence of complications
Time frame: 2023-08-14 to 2027-08-01
The cost-effectiveness ratio
Time frame: 2023-08-14 to 2027-08-01
The emergency readmission time
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.
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.
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.
Time frame: 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 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 survival outcomes were impacted by preoperative pathological diagnosis.
Time frame: 2023-08-14 to 2027-08-01
Maximum lesion size
Time frame: 2023-08-14 to 2027-08-01
Lesion shape
Time frame: 2023-08-14 to 2027-08-01
Lesion composition
Time frame: 2023-08-14 to 2027-08-01
Lesion margin
Time frame: 2023-08-14 to 2027-08-01
Lesion echogenicity
Time frame: 2023-08-14 to 2027-08-01
Lesion heterogeneity
Time frame: 2023-08-14 to 2027-08-01
Lesion growth pattern
Time frame: 2023-08-14 to 2027-08-01
Lesion blood flow
Time frame: 2023-08-14 to 2027-08-01
Lesion elastography
Time frame: 2023-08-14 to 2027-08-01
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Zhong, MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Klatskin Tumor and Cholangiocarcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.