Clinical trial NCT05993429: Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Klatskin Tumor
Cholangiocarcinoma
Biopsy, Fine-Needle
Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: First Affiliated Hospital of Guangxi Medical University
name: LanZhou University
name: Wuhan Union Hospital, China
name: Beijing Friendship Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Binzhou Medical University
name: Shandong Provincial Hospital
name: The Second Hospital of Hebei Medical University
First posted: 2023-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma
timeFrame: 2023-08-14 to 2027-08-01
Secondary outcomes:
measure: The incidence of complications
timeFrame: 2023-08-14 to 2027-08-01
measure: The cost-effectiveness ratio
timeFrame: 2023-08-14 to 2027-08-01
measure: The emergency readmission time
timeFrame: 2023-08-14 to 2027-08-01
measure: The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.
timeFrame: 2023-08-14 to 2027-08-01
measure: The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.
timeFrame: 2023-08-14 to 2027-08-01
measure: The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.
timeFrame: 2023-08-14 to 2027-08-01
measure: The incidence rate of needle tract metastasis by EUS-FNA/B
timeFrame: 2023-08-14 to 2027-08-01
measure: The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.
timeFrame: 2023-08-14 to 2027-08-01
measure: The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.
timeFrame: 2023-08-14 to 2027-08-01
measure: Maximum lesion size
timeFrame: 2023-08-14 to 2027-08-01
measure: Lesion shape
timeFrame: 2023-08-14 to 2027-08-01
measure: Lesion composition
timeFrame: 2023-08-14 to 2027-08-01
measure: Lesion margin
timeFrame: 2023-08-14 to 2027-08-01
measure: Lesion echogenicity
timeFrame: 2023-08-14 to 2027-08-01
measure: Lesion heterogeneity
timeFrame: 2023-08-14 to 2027-08-01
measure: Lesion growth pattern
timeFrame: 2023-08-14 to 2027-08-01
measure: Lesion blood flow
timeFrame: 2023-08-14 to 2027-08-01
measure: Lesion elastography
timeFrame: 2023-08-14 to 2027-08-01
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Ning Zhong, MD
role: PRINCIPAL_INVESTIGATOR
References: