Biopsy, Fine-Needle, Cholangiocarcinoma, Endoscopic Retrograde Cholangiopancreatography, Klatskin Tumor
Conditions
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.
Interventions
DIAGNOSTIC_TESTThe 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.
Sponsors
Qilu Hospital of Shandong University
First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Guangxi Medical University
LanZhou University
Beijing Friendship Hospital
Binzhou Medical University
Shandong Provincial Hospital
Shandong Province Third hospital
Sir Run Run Shaw Hospital
The Third Xiangya Hospital of Central South University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 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. |
| 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 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. |
| Maximum lesion size | 2023-08-14 to 2027-08-01 | Maximum lesion size on EUS |
| Lesion shape | 2023-08-14 to 2027-08-01 | Lesion shape (ovoid-to-round, irregular) on EUS. |
| 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 heterogeneity | 2023-08-14 to 2027-08-01 | Lesion heterogeneity 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORNing Zhong, MD
Qilu Hospital of Shandong University
Outcome results
None listed