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

Study Overview
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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.

Official Title
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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

Conditions
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Klatskin Tumor, Cholangiocarcinoma, Biopsy, Fine-Needle, Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
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* Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old; Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EUS-FNA/B group; ERCP with or without POCS-TB group<br>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<br>* 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.<br>|
| ERCP with or without POCS-TB group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2023-08-20 to 2027-08-01 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of complications | The incidence of complications after EUS-FNA/B versus ERCP with or without POCS-TB | 2023-08-20 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 | 2023-08-20 to 2027-08-01 | 
| The emergency readmission time | The emergency readmission time of EUS-FNA versus 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 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 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. | 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 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 incidence rate of needle tract metastasis by EUS-FNA/B | The incidence rate of needle tract metastasis by EUS-FNA/B | 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 further treatment strategies 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. | The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis. | 2023-08-20 to 2027-08-01 | 
| Maximum lesion size | Maximum lesion size on EUS | 2023-08-20 to 2027-08-01 | 
| Lesion shape | Lesion shape (ovoid-to-round, irregular) on EUS. | 2023-08-20 to 2027-08-01 | 
| Lesion composition | Lesion composition (cystic, partially cystic, solid) on EUS. | 2023-08-20 to 2027-08-01 | 
| Lesion margin | Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS. | 2023-08-20 to 2027-08-01 | 
| Lesion echogenicity | Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS. | 2023-08-20 to 2027-08-01 | 
| Lesion heterogeneity | Lesion heterogeneity on EUS. | 2023-08-20 to 2027-08-01 | 
| Lesion growth pattern | Lesion growth pattern on EUS. | 2023-08-20 to 2027-08-01 | 
| Lesion blood flow | Lesion blood flow (none, poor, moderate, rich) on EUS. | 2023-08-20 to 2027-08-01 | 
| Lesion elastography | Lesion elastography (stiff, moderate, soft, unvalued) on EUS. | 2023-08-20 to 2027-08-01 |