Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver

Learn more about:
Related Clinical Trial
Liver Embolization Approaches for Tumor Management Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status in Cholangiocarcinoma Patients Evaluation of the Patient’s Experience in Medical Studies for Cholangiocarcinoma Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials Advanced or Metastatic Cholangiocarcinoma Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction An Exploratory Clinical Study of Photodynamic Therapy Combined With Sonodynamic Therapy in Cholangiocarcinoma Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma FLUOPANC-trial – Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1 Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma QoL After Liver Surgery CH-EUS in Diagnosis of Inoperable Bile Duct Tumors Treatment of ARB202 Advanced Gastrointestinal Cancer Patients Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines. GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma. Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors Molecular Epidemiology of Biliary Tree Cancers Prognostic Factors in Periampullary Tumors and Cysts RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor HLA Typing and Tumor Neoantigen Identification for a Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor Deep Liver Phenotyping and Immunology Study A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry. Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone Crossover Relative Bioavailability and Dose Escalation Study of TT-00420 Tablet in Patients With Advanced Solid Tumors Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer Open-Label Study for Safety, Tolerability, PK and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma LYT-200 Alone and in Combination With Chemotherapy or Anti-PD-1 in Patients With Metastatic Solid Tumors Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer Phase I/II Study Evaluating Safety and Efficacy of Tivozanib (AV-951) in Cholangiocarcinoma ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY Recurrence After Whipple’s (RAW): Retrospective Cohort Study Investigating Patterns of Cancer Recurrence Following Pancreaticoduodenectomy for Pancreatic Head Malignancy Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care Prospective Evaluation of Biliary Tissue Sampling With ERCP Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture Liver Cancer Registry Platform Target Rare Cancer Knowledge Neoadjuvant Therapy in Biliary Adenocarcinoma BOLD-100 in Combination With FOLFOX for the Treatment of Advanced, Solid Tumours the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery Efficacy of Fistulotomy for Biliary Cannulation A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors Etomidate vs. Midazolam for Sedation During ERCP Loop-tipped Guidewire in Selective Biliary Cannulation Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT) Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm BKM120 in Cancers With PIK3CA Activating Mutations A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT PTFE Stents for Treatment of Malignant Biliary Strictures Irreversible Electroporation of Unresectable Liver Tumors Personal Resilience Empowerment Program Study Radiofrequency Ablation for Biliopancreatic Malignancy Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer In Vitro Models of Liver and Pancreatic Cancer Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter Evaluation of Stereotactic Radiosurgery For Liver Malignancies Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD Margin Status After Pancreaticoduodenectomy for Cancer A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer A Study of TRK-950 in Patients With Advanced Solid Tumors Combined HCC-MFCCC Proton Therapy and Bevacizumab for Primary Liver Tumors Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases Fluorescence QRH-882260 Peptide Imaging in the Bile Duct A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer MRCP Diagnoses EHCC Better When Combined DWI Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours Comparison of Biliary Forceps Biopsy and Brush Cytology Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer Endobiliary RFA for Unresectable Malignant Biliary Strictures A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma Clinical Effect and Safety of PDT and RFA for Unresectable EHCC Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma Trial of IRE in Cholangiocarcinoma Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer S-1 in Combination With Abraxane in Treating Cholangiocarcinoma Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy – (FIGHT-202) Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Study of Pembrolizumab and Olaparib in Bile Duct Cancer Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma ncRNAs in Exosomes of Cholangiocarcinoma Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

Brief Title

Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver

Official Title

Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver - A Prospective Study

Brief Summary

      The diagnostic accuracy of EUS for detection of the liver tumors (primary and metastatic)
      remains unknown. To compare the accuracy of the EUS and CT scan for detection of the primary
      and metastatic carcinoma of the liver.

Detailed Description

      The incidence of hepatocellular carcinoma is increasing in US. The reason for this increase
      has been attributed to the emergence of hepatitis C. Studies suggest that patients with
      hepatitis C are at higher risk of developing hepatocellular carcinoma (elevated
      alpha-fetoprotein) and, therefore should undergo periodic radiological investigation.

      The liver is also a common site for metastases for various malignancies. The metastasis to
      liver profoundly affects the management and prognosis, since these patients have advanced
      cancer and therefore are not candidates for surgery.

      1.1 Current standards of care

      For primary liver tumors alpha-fetoprotein, abdominal ultrasound and CT scan of the abdomen
      are the suggested tests for the screening in patients that are at higher risk of developing
      this complication. Measurement of serum alpha-fetoprotein (AFP) may be helpful in the
      diagnosis and management of HCC. AFP is elevated above 20 ng/Ml in more than 70% of patients
      with HCC. However, AFP elevations from 10-500 ng/Ml and even occasionally to 1000 ng/ml may
      be seen in patients with a high degree of inflammatory activity such as with chronic viral
      hepatitis, who do not have HCC (3). The sensitivity, specificity, and positive predictive
      value of AFP in 3 well performed screening studies for HCC ranged from 39%-64%, 76%-91%, and
      9%-32%, respectively (4). Imaging studies play a key role in the diagnosis of HCC since a
      significant number of cases are missed by AFP. CT scan and magnetic resonance imaging are
      commonly used tests.

      On the basis of studies conducted over last two decades, National Comprehensive Cancer
      Network (2004) guidelines for the management of cancer recommended CT scan for the evaluation
      of the liver for metastases (Please refer to appendix III).

      Recent studies have shown that CT scan is far from ideal for detection of primary as well as
      metastases to liver (5,6). A well designed study showed that CT scan missed 32 % of the
      primary tumors of the liver. A prospective study of 100 patients with colorectal cancer
      showed that CT scan missed liver metastases in 37% of cases (5). Another prospective
      controlled study of 135 subjects showed that CT scan failed to detect liver metastases in 49%
      of patients with various malignancies (6).

      1.2 EUS as a possible diagnostic tool for liver tumors EUS is a well-established tool for the
      diagnosis and/ or staging of the esophageal, gastric and pancreatic cancer. Recent studies
      have shown a potential role of EUS for the liver imaging (7, 8, and 9).

      1.3 Comparison of EUS and CT scan for detection of liver metastases

      Studies suggest that EUS may be an attractive alternative to CT scan for detection of the
      liver metastases, since it can detect lesions that are missed on the CT scan (9). EUS
      detected metastatic lesions overlooked by conventional, cross-sectional imaging studies in 5
      of 222 cases (2.3%) (9). Another study found occult liver metastases in 2.4% of 574 patients
      with suspected GI or pulmonary malignancies (4). Each patient found to have occult metastases
      at EUS had staging CT, which raises an issue as to the quality and/or interpretation of those

      An additional advantage of EUS is that fine needle aspiration (FNA) can be performed
      simultaneously and therefore confirmation of malignancy can usually be accomplished in a
      single procedure whereas CT or US typically require 2 sessions to accomplish these tasks, one
      for detection and another for FNA.

      1.4 Limitation of EUS: Right lobe The limitation of the EUS is that it is not able to examine
      the right lobe of the liver completely.

      1.5 Rationale for the study. The diagnostic accuracy of EUS for detection of the liver tumors
      (primary and metastatic) remains unknown. There is sufficient evidence to suggest that EUS
      may be superior to the CT scan for the liver metastases. Studies that have evaluated the role
      of EUS are limited by small sample size or retrospective design. Therefore, a prospective
      study with adequate sample size is required to determine the diagnostic accuracy of endoscopy

      2.0 Objectives:

      2.1 Primary:

      To compare the accuracy of the EUS and CT scan for detection of the primary and metastatic
      carcinoma of the liver.

      2.2 Secondary: 2.2.1 Determine the diagnostic yield of fine needle aspiration using EUS
      (EUS-FNA) in patients with suspected liver metastasis on EUS examination.

      2.2.2 Compare the accuracy of the PET scan with EUS for the detection of the liver

      2.2.3 Determine the safety of EUS-FNA in subjects with liver lesions. 2.2.4 Impact of the EUS
      on the management of the hepatocellular carcinoma 2.2.5 To study characteristic
      echoendoscopic findings of the primary and secondary liver tumor.

      2.3 Hypothesis: 2.3.1 EUS is likely to detect primary tumor and liver metastasis in subjects
      with normal CT scan.

      3.0 Design: This is a prospective study where study group would comprise of consecutive
      patients with newly diagnosed colon, pancreatic, esophageal, lung, gastric cancer and patient
      with hepatitis C or B with elevated levels of alpha-fetoprotein or radiological findings
      suggestive of mass in the liver.

      Patients would be selected from gastroenterology clinic, primary care clinic, surgery clinic,
      sub-specialty clinics (Oncology, Pulmonary) and hepatitis C clinic. These clinics would be
      informed about the ongoing EUS study and the eligibility criteria's of the study. All
      patients will be seen in the gastroenterology clinic where a detail description of the
      EUS-FNA procedure would be provided to them. In addition, patients would be provided consent
      forms. (Please refer to section 5 for details of the consent process.)

      Study population:

      Enrollment of participants.

      Patients enrolled in the study would undergo -

        -  Detailed history and physical examination,

        -  CT-abdomen preferably with contrast, and

        -  Possible PET scan. PET scan will be performed on patients who do not have evident
           distant metastasis.

        -  Intervention allocation: all eligible patients would be encouraged to undergo EUS and
           EUS-FNA examination.


      Description and schedule: All eligible patients would undergo EUS examination of the liver.
      Any subject with abnormality suspicious for malignancy in liver would undergo FNA.

      Follow-up visits description and schedule. After the procedure patient would be referred back
      to the clinic from which the patient was identified for further management. These patients
      are usually seen by oncologists, pulmonologists and cardio-thoracic surgeon depending on the
      stage and the medical condition of the patient.

Study Phase

Phase 2

Study Type


Primary Outcome

To compare the accuracy of the EUS and CT scan for detection of the primary and metastatic carcinoma of the liver.

Secondary Outcome



Hepatocellular Carcinoma


Endoscopy ultrasound


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Start Date

July 2004

Completion Date

January 2006

Eligibility Criteria

        Inclusion Criteria:

        Patients with newly diagnosed colon, pancreatic, esophageal, lung, gastric cancer and
        patient with hepatitis C or B with elevated levels of alpha-fetoprotein or radiological
        findings suggestive of mass in the liver.

        Exclusion Criteria:

          -  Advanced heart or lung disease that precludes conscious sedation

          -  Liver failure




N/A - N/A

Accepts Healthy Volunteers



Pankaj Singh, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Study Sponsor

Central Texas Veterans Health Care System

Study Sponsor

Pankaj Singh, MD, Principal Investigator, Central Texas Veterans Health Care System

Verification Date

January 2006