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
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Qilu Hospital of Shandong University | Jinan | Shandong |
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 |
China,
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 |
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