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Completed

NCT Number: NCT05993429

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

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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Key information

Conditions

Klatskin Tumor Adenocarcinoma Biopsy, Fine-needle Carcinoma Cholangiocarcinoma Endoscopic Retrograde Cholangiopancreatography Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years old;
  • Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination

Exclusion criteria

  • Patients with a definite diagnosis of cholangiocarcinoma by imaging (enhanced CT, MRI, or MRCP) and surgical candidacy within 3 months;
  • Patients scheduled for liver transplantation;
  • Patients with previous gastroduodenal diversion or biliary surgery;
  • Patients with hilar bile duct stenosis caused by tumor or lesion outside the bile duct;
  • Pregnant or lactating women;
  • Patients who cannot tolerate intravenous general anesthesia due to various reasons;
  • 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;
  • Patients who refused to sign informed consent.

Treatment and study plan

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.

Primary outcomes

  1. The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma

    Time frame: 2023-08-14 to 2027-08-01

    The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.

Secondary outcomes

  1. The incidence of complications

    Time frame: 2023-08-14 to 2027-08-01

    The incidence of complications after EUS-FNA/B versus ERCP with or without POCS-TB

  2. The cost-effectiveness ratio

    Time frame: 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

  3. The emergency readmission time

    Time frame: 2023-08-14 to 2027-08-01

    The emergency readmission time of EUS-FNA versus ERCP with or without POCS-TB

  4. The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.

    Time frame: 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.

  5. The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.

    Time frame: 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.

  6. The number of participants whose management was affected by the new generation of Eye Max cholangioscopy visual diagnosis.

    Time frame: 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.

  7. The incidence rate of needle tract metastasis by EUS-FNA/B

    Time frame: 2023-08-14 to 2027-08-01

    The incidence rate of needle tract metastasis by EUS-FNA/B

  8. The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.

    Time frame: 2023-08-14 to 2027-08-01

    The number of participants whose further treatment strategies were impacted by preoperative pathological diagnosis.

  9. The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.

    Time frame: 2023-08-14 to 2027-08-01

    The number of participants whose survival outcomes were impacted by preoperative pathological diagnosis.

  10. Maximum lesion size

    Time frame: 2023-08-14 to 2027-08-01

    Maximum lesion size on EUS

  11. Lesion shape

    Time frame: 2023-08-14 to 2027-08-01

    Lesion shape (ovoid-to-round, irregular) on EUS.

  12. Lesion composition

    Time frame: 2023-08-14 to 2027-08-01

    Lesion composition (cystic, partially cystic, solid) on EUS.

  13. Lesion margin

    Time frame: 2023-08-14 to 2027-08-01

    Lesion margin (ill-defined, microlobulated/spiculated, well-defined) on EUS.

  14. Lesion echogenicity

    Time frame: 2023-08-14 to 2027-08-01

    Lesion echogenicity (hyperechoic intensity, isoechoic intensity, hypoechoic intensity) on EUS.

  15. Lesion heterogeneity

    Time frame: 2023-08-14 to 2027-08-01

    Lesion heterogeneity on EUS.

  16. Lesion growth pattern

    Time frame: 2023-08-14 to 2027-08-01

    Lesion growth pattern on EUS.

  17. Lesion blood flow

    Time frame: 2023-08-14 to 2027-08-01

    Lesion blood flow (none, poor, moderate, rich) on EUS.

  18. Lesion elastography

    Time frame: 2023-08-14 to 2027-08-01

    Lesion elastography (stiff, moderate, soft, unvalued) on EUS.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Beijing Friendship Hospital
  • Binzhou Medical University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital, Sun Yat-Sen University
  • LanZhou University
  • Shandong Province Third hospital
  • Shandong Provincial 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

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2023
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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