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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| LanZhou University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The sampling method selected in patients with suspected hilar cholangiocarcinoma | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Ning Zhong, MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | 250063 | China |
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| Beijing Friendship Hospital |
| OTHER |
| Binzhou Medical University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Shandong Province Third hospital | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
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| 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 |
| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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