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Trial Title:
Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma
NCT ID:
NCT05993429
Condition:
Klatskin Tumor
Cholangiocarcinoma
Biopsy, Fine-Needle
Endoscopic Retrograde Cholangiopancreatography
Conditions: Official terms:
Cholangiocarcinoma
Klatskin Tumor
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
The sampling method selected in patients with suspected hilar cholangiocarcinoma
Description:
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.
Arm group label:
ERCP with or without POCS-TB group
Arm group label:
EUS-FNA/B group; ERCP with or without POCS-TB group
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250063
Country:
China
Status:
Recruiting
Start date:
August 14, 2023
Completion date:
August 1, 2027
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
LanZhou University
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Collaborator:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Binzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
The Second Hospital of Hebei Medical University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05993429
