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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cholangiocarcinoma; Endoscopic Retrograde Cholangiopancreatography; Klatskin Tumor; Biopsy, Fine-Needle
• Intervention / Treatment: Diagnostic test: The sampling method selected in patients with suspected hilar cholangiocarcinoma

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Zhen Li, MD; Phone Number: 18560086106; Email: qilulizhen@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250063
      • Recruiting
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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.	2023-08-14 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	2023-08-14 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	2023-08-14 to 2027-08-01
The emergency readmission time	The emergency readmission time of EUS-FNA versus 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 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 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.	2023-08-14 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.	2023-08-14 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	2023-08-14 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.	2023-08-14 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.	2023-08-14 to 2027-08-01
Maximum lesion size	Maximum lesion size on EUS	2023-08-14 to 2027-08-01
Lesion shape	Lesion shape (ovoid-to-round, irregular) on EUS.	2023-08-14 to 2027-08-01
Lesion composition	Lesion composition (cystic, partially cystic, solid) on EUS.	2023-08-14 to 2027-08-01
Lesion margin	Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.	2023-08-14 to 2027-08-01
Lesion echogenicity	Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.	2023-08-14 to 2027-08-01
Lesion heterogeneity	Lesion heterogeneity on EUS.	2023-08-14 to 2027-08-01
Lesion growth pattern	Lesion growth pattern on EUS.	2023-08-14 to 2027-08-01
Lesion blood flow	Lesion blood flow (none, poor, moderate, rich) on EUS.	2023-08-14 to 2027-08-01
Lesion elastography	Lesion elastography (stiff, moderate, soft, unvalued) on EUS.	2023-08-14 to 2027-08-01

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: LanZhou University; Beijing Friendship Hospital; The Second Hospital of Hebei Medical University; First Affiliated Hospital, Sun Yat-Sen University; Shandong Provincial Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Wuhan Union Hospital, China; First Affiliated Hospital of Guangxi Medical University; Binzhou Medical University
• Investigators: Principal Investigator: Ning Zhong, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: 2023SDU-QILU-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No