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

Recruiting

• Conditions: Biopsy, Fine-Needle; Endoscopic Retrograde Cholangiopancreatography; Klatskin Tumor; Cholangiocarcinoma
• Interventions: Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma

• Registration Number: NCT05993429
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-13
• Study Start: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-15
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERCP with or without POCS-TB group	The sampling method selected in patients with suspected hilar cholangiocarcinoma	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
EUS-FNA/B group; ERCP with or without POCS-TB group	The sampling method selected in patients with suspected hilar cholangiocarcinoma	EUS-FNA/B group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B by experts

Primary Outcome Measures

Name	Time	Method
The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma	2023-08-14 to 2027-08-01	The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.

Secondary Outcome Measures

Name	Time	Method
Lesion shape	2023-08-14 to 2027-08-01	Lesion shape (ovoid-to-round, irregular) on EUS.
The incidence rate of needle tract metastasis by EUS-FNA/B	2023-08-14 to 2027-08-01	The incidence rate of needle tract metastasis by EUS-FNA/B
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 visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.
Lesion composition	2023-08-14 to 2027-08-01	Lesion composition (cystic, partially cystic, solid) on EUS.
Lesion margin	2023-08-14 to 2027-08-01	Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.
Lesion echogenicity	2023-08-14 to 2027-08-01	Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.
Lesion growth pattern	2023-08-14 to 2027-08-01	Lesion growth pattern on EUS.
Lesion blood flow	2023-08-14 to 2027-08-01	Lesion blood flow (none, poor, moderate, rich) on EUS.
Lesion elastography	2023-08-14 to 2027-08-01	Lesion elastography (stiff, moderate, soft, unvalued) on EUS.
The cost-effectiveness ratio	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
The emergency readmission time	2023-08-14 to 2027-08-01	The emergency readmission time of EUS-FNA versus ERCP with or without POCS-TB
Maximum lesion size	2023-08-14 to 2027-08-01	Maximum lesion size on EUS
Lesion heterogeneity	2023-08-14 to 2027-08-01	Lesion heterogeneity on EUS.
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 further treatment strategies were impacted by preoperative pathological diagnosis.
The number of participants whose survival outcomes 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.
The incidence of complications	2023-08-14 to 2027-08-01	The incidence of complications after EUS-FNA/B 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.	2023-08-14 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 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 number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China