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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05993429
• Other study ID #: 2023SDU-QILU-3
• Status: Recruiting
• Start date: August 14, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: July 2023
• Source: Qilu Hospital of Shandong University
• Contact: Zhen Li, MD
• Phone: 18560086106
• Email: qilulizhen[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (10)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Beijing Friendship Hospital, Binzhou Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital, Sun Yat-Sen University, LanZhou University, Shandong Provincial Hospital, The Second Hospital of Hebei Medical University, Third Affiliated Hospital, Sun Yat-Sen University, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maximum lesion size	Maximum lesion size on EUS	2023-08-14 to 2027-08-01
Secondary	Lesion shape	Lesion shape (ovoid-to-round, irregular) on EUS.	2023-08-14 to 2027-08-01
Secondary	Lesion composition	Lesion composition (cystic, partially cystic, solid) on EUS.	2023-08-14 to 2027-08-01
Secondary	Lesion margin	Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.	2023-08-14 to 2027-08-01
Secondary	Lesion echogenicity	Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.	2023-08-14 to 2027-08-01
Secondary	Lesion heterogeneity	Lesion heterogeneity on EUS.	2023-08-14 to 2027-08-01
Secondary	Lesion growth pattern	Lesion growth pattern on EUS.	2023-08-14 to 2027-08-01
Secondary	Lesion blood flow	Lesion blood flow (none, poor, moderate, rich) on EUS.	2023-08-14 to 2027-08-01
Secondary	Lesion elastography	Lesion elastography (stiff, moderate, soft, unvalued) on EUS.	2023-08-14 to 2027-08-01