Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma [2023-08-20 to 2027-08-01]
The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.
Secondary Outcome Measures
- The incidence of complications [2023-08-20 to 2027-08-01]
The incidence of complications after EUS-FNA/B versus ERCP with or without POCS-TB
- The cost-effectiveness ratio [2023-08-20 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
- The emergency readmission time [2023-08-20 to 2027-08-01]
The emergency readmission time of EUS-FNA versus 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. [2023-08-20 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 number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively. [2023-08-20 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 management was affected by the new generation of Eye Max cholangioscopy visual diagnosis. [2023-08-20 to 2027-08-01]
The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.
- The incidence rate of needle tract metastasis by EUS-FNA/B [2023-08-20 to 2027-08-01]
The incidence rate of needle tract metastasis by EUS-FNA/B
- The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis. [2023-08-20 to 2027-08-01]
The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.
- The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis. [2023-08-20 to 2027-08-01]
The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.
- Maximum lesion size [2023-08-20 to 2027-08-01]
Maximum lesion size on EUS
- Lesion shape [2023-08-20 to 2027-08-01]
Lesion shape (ovoid-to-round, irregular) on EUS.
- Lesion composition [2023-08-20 to 2027-08-01]
Lesion composition (cystic, partially cystic, solid) on EUS.
- Lesion margin [2023-08-20 to 2027-08-01]
Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.
- Lesion echogenicity [2023-08-20 to 2027-08-01]
Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.
- Lesion heterogeneity [2023-08-20 to 2027-08-01]
Lesion heterogeneity on EUS.
- Lesion growth pattern [2023-08-20 to 2027-08-01]
Lesion growth pattern on EUS.
- Lesion blood flow [2023-08-20 to 2027-08-01]
Lesion blood flow (none, poor, moderate, rich) on EUS.
- Lesion elastography [2023-08-20 to 2027-08-01]
Lesion elastography (stiff, moderate, soft, unvalued) on EUS.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-80 years old;
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Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination
Exclusion Criteria:
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Patients with a definite diagnosis of cholangiocarcinoma by imaging (enhanced CT, MRI, or MRCP) and surgical candidacy within 3 months;
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Patients scheduled for liver transplantation;
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patients with previous gastroduodenal diversion or biliary surgery;
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Patients with hilar bile duct stenosis caused by tumor or lesion outside the bile duct;
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Pregnant or lactating women;
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Patients who cannot tolerate intravenous general anesthesia due to various reasons;
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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;
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Patients who refused to sign informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital of Shandong University | Jinan | Shandong | China | 250063 |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
- First Affiliated Hospital, Sun Yat-Sen University
- First Affiliated Hospital of Guangxi Medical University
- LanZhou University
- Sir Run Run Shaw Hospital
- Wuhan Union Hospital, China
Investigators
- Principal Investigator: Ning Zhong, MD, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023SDU-QILU-3