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

• 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

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 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.
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.
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
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.
Lesion shape	2023-08-14 to 2027-08-01	Lesion shape (ovoid-to-round, irregular) on EUS.

Trial Locations

Locations (1)

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