Improving Genomic Profiling and Reducing Time to Cancer Treatment Via Targeted Use of Endoscopic Ultrasound
NCT ID: NCT06848738
Last Updated: 2025-02-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ENROLLING_BY_INVITATION
Clinical Phase
NA
Total Enrollment
362 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-05-07
Study Completion Date
2026-06-01
Brief Summary
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Aim:
To investigate whether the novel 3rd generation FNB needle provides a better diagnostic accuracy than a standard FNA needle in EUS-B guided diagnosis of common deep seated thoracic malignancies (lung cancer and lymphoma).
Short study description:
Consecutive patients referred due to suspected cancer with enlarged (at least 10 mm in the shortest axis) and/or FDG-avid lymph nodes or other lesions adjacent to the esophagus/stomach (e.g. suspected liver metastasis), thus with an indication for EUS-B, will be randomly assigned for tissue sampling either with a standard 22G FNA needle, or the novel 22G crown-cut FNB needle.
280 patients with suspected lung cancer will be included and inclusion will end when the targeted number of 254 patients (127 in each group) with a final diagnosis of lung cancer is reached.
Likewise, 82 patients with suspected lymphoma will be included until the targeted number of 74 patients (37 in each group) with a final diagnosis of lymphoma or sarcoidosis is reached.
Primary outcome: proportion of patients with a comprehensive diagnostic result in each needle arm for patients with lung cancer and lymphoma / sarcoidosis.
To investigate whether the novel 3rd generation FNB needle provides a better diagnostic accuracy than a standard FNA needle in EUS-B guided diagnosis of common deep seated thoracic malignancies (lung cancer and lymphoma).
Short study description:
Consecutive patients referred due to suspected cancer with enlarged (at least 10 mm in the shortest axis) and/or FDG-avid lymph nodes or other lesions adjacent to the esophagus/stomach (e.g. suspected liver metastasis), thus with an indication for EUS-B, will be randomly assigned for tissue sampling either with a standard 22G FNA needle, or the novel 22G crown-cut FNB needle.
280 patients with suspected lung cancer will be included and inclusion will end when the targeted number of 254 patients (127 in each group) with a final diagnosis of lung cancer is reached.
Likewise, 82 patients with suspected lymphoma will be included until the targeted number of 74 patients (37 in each group) with a final diagnosis of lymphoma or sarcoidosis is reached.
Primary outcome: proportion of patients with a comprehensive diagnostic result in each needle arm for patients with lung cancer and lymphoma / sarcoidosis.
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Detailed Description
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Overall aim:
To investigate whether the novel FNB needle provides a better diagnostic accuracy than a standard FNA needle in EUS-B guided cancer diagnosis.
Design:
Prospective multicenter randomized control superiority study.
Primary study objective:
Comparing the ability to provide comprehensive phenotyping from microscopy histology/cytology to the molecular level to allow for optimal and early personalized cancer-specific therapy of FNA and FNB from tumors and lymph nodes adjacent to the esophagus/stomach using EUS-B in patients referred with suspected cancer.
The main focus are common deep-seated malignancies: NSCLC and lymphoma.
Study description:
Consecutive patients referred due to suspected cancer with enlarged (at least 10 mm in the shortest axis) and/or FDG-avid lymph nodes or other lesions adjacent to the esophagus/stomach (e.g. suspected liver metastasis), thus with an indication for EUS-B, will be randomly assigned for tissue sampling either with a standard 22G FNA needle, or the novel 22G crown-cut FNB needle.
280 patients with suspected lung cancer will be included and inclusion will end when the targeted number of 254 patients (127 in each group) with a final diagnosis of NSCLC is reached (see under statistics).
Likewise, 82 patients with suspected lymphoma will be included until the targeted number of 74 patients (37 in each group) with a final diagnosis of lymphoma is reached (see under statistics).
Needles:
The standard needle for EUS-B is a 21G or 22G FNA-needle (fine needle aspiration), but new needles have been developed to obtain more histological material for immuno-histochemistry and mutation analyses. Larger biopsy specimens increase the diagnostic yield and allows for more mutation analyses, yet sample quality is not only determined by volume: larger tissue volume is obtained with a 19G versus a 22G FNA needle but with identical diagnostic yield.
Tissue volume seems also increased with EBUS using a 22G needle with a novel three-point crown-cut design (Franseen needle design) compared to a standard 22G FNA. However, the diagnostic yield did not increase, and one of the reasons addressed was the inability to penetrate the tracheal/bronchial cartilage (which is not at problem in EUS-B). Safety and adverse events did not differ from FNA.
Crown-cut needles belongs to the third generation of fine needle biopsy needles (FNB). Within the third generation of FNB needles, studies comparing the different designs found that FNB needles with a multifaceted tip (crown-cut and fork-tip needles) were more superior than other designs of the same generation.
No study has investigated the use of the FNB needle in EUS-B. On this background, in the EUS-B study the investigator describe a systematic evaluation of the diagnostic superiority of a novel 3rd generation 22G FNB needle (SonoTip TopGain®, MediGlobe, Germany) over standard FNA, as well as evaluating its safety in EUS-B.
Study conduct:
Recruitment and informed consent:
The investigator will recruit participants to the study among patients referred to the study sites with suspected cancer. Upon planning the diagnostic procedure, the doctor assesses if the patient can be included in the study. Here, the patient will receive oral information about the study by a healthcare professional who is familiar with the study. The conversation will take place in undisturbed conditions, where the patient can bring a co-sitter.
The patient will the receive a written information about the study, as well as a document explaining research participants rights in a health science research project as well as contact information about the research responsible doctor.
24 hour consideration period is given to the patient who will be able to contact the research responsible doctor with questions about the study.
The patient can be included in the study once both the healthcare professional and the patient have signed the written informed consent document.
The patient have will have the ability to withdraw from the study at any time and without any consequences on further diagnostic investigation or treatment.
Recruitment will begin in Region Zealand (Næstved and Roskilde) and once the study is established, a cooperation agreement as well as data processing agreement will be made with Odense University Hospital.
The EUS-B procedure:
The patients will be allocated to one of two groups based on either suspected lung cancer or deep-seated lymphoma. In each group, randomization will be performed in a 1:1 ratio using an online password-protected computer-generated system (RedCap). Moreover, randomization will be stratified based on cancer history, to ensure that there will be as many with suspected first time lung cancer or lymphoma and suspected recurrence/progression of a known cancer in each group.
If the patient is found suitable for inclusion and informed consent is obtained, the patient is immediately randomized to sampling with either FNA or FNB prior to the procedure.
The diagnostic work-up will be performed under conscious sedation as an out-patient procedure. After bronchoscopy (and EBUS if indicated), EUS-B is performed by sliding a linear EBUS echo-endoscope down the esophagus.
Sampling technique will be identical for both needles. Sampling, using an inner-stylet, will be performed by minimum two needle-passes per station using a fanning technique with suction. However, number of needle-passes might change if the operator finds it indicated, and it will be noted. Aspirates will be transferred to a dedicated container containing formalin, and at least one smear is produced on a glass slide. Samples are marked with patient ID and lesion location.
The pathologist will be blinded to group allocation. Only the study coordinator will have access to the randomization module.
Rapid on-site evaluation (ROSE) is not available at the study sites and will therefore not be utilized in the present study.
The diagnostic procedures will be performed by endoscopy experienced pulmonologists (minimum 200 EUS-B performed) from the respiratory department of each of the following Hospitals:
* Zealand University Hospital, Næstved
* Zealand University Hospital, Roskilde
* Odense University Hospital, Odense
Biological Material:
Needle biopsies of suspicious lesions are sent as per normal clinical practice to the Department of Pathology, where the material will be examined for the presence of cancer cells and genomic analyses will be performed when Non-Small Cell Lung Cancer (NSCLC) is found.
Tissue material will as usual practice be received and analyzed at the Department of Pathology, where they have a Diagnostic Biobank to store tissue samples. This is not specific to this research study, and the investigator will not store any tissue after analysis.
Specimen processing:
All material will be prepared as per clinical standard, where tissue micro cores will be processed as cell blocks with formalin fixation and paraffin embedding. Smears are airdried for May-Grünwald-Giemsa staining. Each cell block will be stained with haematoxylin and eosin, and when relevant immunohistochemical stains specific for lung cancer will be used. In case of other cancer, supplementary stains will be used according to standard regimens. Tissue is additionally sent for flow cytometry in dedicated glass tubes when lymphoma is suspected.
Diagnostic accuracy:
Diagnostic accuracy of FNA and FNB will be compared and estimated using the equation "diagnostic sample/all samples". Specimens will be evaluated according to a local modified version of the Papanicolau classification of pulmonary specimens and categorized as either:
I. Non-suitable II. Negative for malignancy III. Atypical cells (e.g. inflammatory or reactive changes) IV. Suspicious for malignancy V. Malignant
Mutational analysis:
Following tumor content evaluation of hematoxylin and eosin-stained slides, and NSCLC is concluded, relevant regions are macrodissected and subjected to a standard genomic DNA extraction procedure using the GeneRead DNA FFPE Kit (Qiagen). DNA-concentration is estimated using a Qubit Fluorometer. All methods are carried out in accordance with the manufacturer's guidelines with at least 20 % neoplastic content (estimated by pathologist) in each tissue sample. Next-Generation Sequencing (NGS) using the available NGS assay at the Department of Pathology will be performed on all NSCLC patients regardless of subtype.
The focus of the investigatior will be on the lung cancer associated biomarkers e.g. ALK, BRAF, EGFR, ERBB2, KRAS and MET.
Regarding lymphoma, analysis of tissue material will follow the normal clinical practice at the study sites, where subtyping is primarily based on immunohistochemistry and flowcytometry. The above mentioned NGS assay is performed in cases where tissue material is sparse. NGS is then necessary for classification of lymphoma subtype.
Statistics:
For the suspected lung cancer subgroup:
Sample size calculation was based on expected difference in prevalence of successful comprehensive targeted genomic profiling of 13% (77% in FNA vs 90% in core needle biopsy, CNB). With 80% power (1-beta), significance level (alpha 0.05) this yields 254 patients. It is expected that 10% (26 patients) will have other diagnoses, so the number of included participants has to be 280 patients to diagnose 127 with NSCLC in each group (FNA vs FNB).
For the suspected lymphoma subgroup:
Sample size calculation was based on expected difference in diagnostic accuracy of 31.30% with transesophageal sampling of deep-seated lymphoma (91.30% in EUS-FNB and 60% in EUS-FNA). With 90% power (1-beta) and significance level (alpha) 0.05 this yields 74 patients.
It is expected that around 10% (8 patients) will have other diagnoses, so the investigator must include 82 patients to diagnose 37 patients in each group.
Descriptive and analytical statistics will be performed using dedicated statistical software (STATA18.0; StataCorp®, Texas, US). Categorical data will be described as number (n) and percentage (%), and continuous variables as median and range. Intergroup differences in categorical variables will be analysed with Chi2-test or Fisher's test (if applicable), and differences in continuous variables with Mann-Whitney U-test.
To investigate whether the novel FNB needle provides a better diagnostic accuracy than a standard FNA needle in EUS-B guided cancer diagnosis.
Design:
Prospective multicenter randomized control superiority study.
Primary study objective:
Comparing the ability to provide comprehensive phenotyping from microscopy histology/cytology to the molecular level to allow for optimal and early personalized cancer-specific therapy of FNA and FNB from tumors and lymph nodes adjacent to the esophagus/stomach using EUS-B in patients referred with suspected cancer.
The main focus are common deep-seated malignancies: NSCLC and lymphoma.
Study description:
Consecutive patients referred due to suspected cancer with enlarged (at least 10 mm in the shortest axis) and/or FDG-avid lymph nodes or other lesions adjacent to the esophagus/stomach (e.g. suspected liver metastasis), thus with an indication for EUS-B, will be randomly assigned for tissue sampling either with a standard 22G FNA needle, or the novel 22G crown-cut FNB needle.
280 patients with suspected lung cancer will be included and inclusion will end when the targeted number of 254 patients (127 in each group) with a final diagnosis of NSCLC is reached (see under statistics).
Likewise, 82 patients with suspected lymphoma will be included until the targeted number of 74 patients (37 in each group) with a final diagnosis of lymphoma is reached (see under statistics).
Needles:
The standard needle for EUS-B is a 21G or 22G FNA-needle (fine needle aspiration), but new needles have been developed to obtain more histological material for immuno-histochemistry and mutation analyses. Larger biopsy specimens increase the diagnostic yield and allows for more mutation analyses, yet sample quality is not only determined by volume: larger tissue volume is obtained with a 19G versus a 22G FNA needle but with identical diagnostic yield.
Tissue volume seems also increased with EBUS using a 22G needle with a novel three-point crown-cut design (Franseen needle design) compared to a standard 22G FNA. However, the diagnostic yield did not increase, and one of the reasons addressed was the inability to penetrate the tracheal/bronchial cartilage (which is not at problem in EUS-B). Safety and adverse events did not differ from FNA.
Crown-cut needles belongs to the third generation of fine needle biopsy needles (FNB). Within the third generation of FNB needles, studies comparing the different designs found that FNB needles with a multifaceted tip (crown-cut and fork-tip needles) were more superior than other designs of the same generation.
No study has investigated the use of the FNB needle in EUS-B. On this background, in the EUS-B study the investigator describe a systematic evaluation of the diagnostic superiority of a novel 3rd generation 22G FNB needle (SonoTip TopGain®, MediGlobe, Germany) over standard FNA, as well as evaluating its safety in EUS-B.
Study conduct:
Recruitment and informed consent:
The investigator will recruit participants to the study among patients referred to the study sites with suspected cancer. Upon planning the diagnostic procedure, the doctor assesses if the patient can be included in the study. Here, the patient will receive oral information about the study by a healthcare professional who is familiar with the study. The conversation will take place in undisturbed conditions, where the patient can bring a co-sitter.
The patient will the receive a written information about the study, as well as a document explaining research participants rights in a health science research project as well as contact information about the research responsible doctor.
24 hour consideration period is given to the patient who will be able to contact the research responsible doctor with questions about the study.
The patient can be included in the study once both the healthcare professional and the patient have signed the written informed consent document.
The patient have will have the ability to withdraw from the study at any time and without any consequences on further diagnostic investigation or treatment.
Recruitment will begin in Region Zealand (Næstved and Roskilde) and once the study is established, a cooperation agreement as well as data processing agreement will be made with Odense University Hospital.
The EUS-B procedure:
The patients will be allocated to one of two groups based on either suspected lung cancer or deep-seated lymphoma. In each group, randomization will be performed in a 1:1 ratio using an online password-protected computer-generated system (RedCap). Moreover, randomization will be stratified based on cancer history, to ensure that there will be as many with suspected first time lung cancer or lymphoma and suspected recurrence/progression of a known cancer in each group.
If the patient is found suitable for inclusion and informed consent is obtained, the patient is immediately randomized to sampling with either FNA or FNB prior to the procedure.
The diagnostic work-up will be performed under conscious sedation as an out-patient procedure. After bronchoscopy (and EBUS if indicated), EUS-B is performed by sliding a linear EBUS echo-endoscope down the esophagus.
Sampling technique will be identical for both needles. Sampling, using an inner-stylet, will be performed by minimum two needle-passes per station using a fanning technique with suction. However, number of needle-passes might change if the operator finds it indicated, and it will be noted. Aspirates will be transferred to a dedicated container containing formalin, and at least one smear is produced on a glass slide. Samples are marked with patient ID and lesion location.
The pathologist will be blinded to group allocation. Only the study coordinator will have access to the randomization module.
Rapid on-site evaluation (ROSE) is not available at the study sites and will therefore not be utilized in the present study.
The diagnostic procedures will be performed by endoscopy experienced pulmonologists (minimum 200 EUS-B performed) from the respiratory department of each of the following Hospitals:
* Zealand University Hospital, Næstved
* Zealand University Hospital, Roskilde
* Odense University Hospital, Odense
Biological Material:
Needle biopsies of suspicious lesions are sent as per normal clinical practice to the Department of Pathology, where the material will be examined for the presence of cancer cells and genomic analyses will be performed when Non-Small Cell Lung Cancer (NSCLC) is found.
Tissue material will as usual practice be received and analyzed at the Department of Pathology, where they have a Diagnostic Biobank to store tissue samples. This is not specific to this research study, and the investigator will not store any tissue after analysis.
Specimen processing:
All material will be prepared as per clinical standard, where tissue micro cores will be processed as cell blocks with formalin fixation and paraffin embedding. Smears are airdried for May-Grünwald-Giemsa staining. Each cell block will be stained with haematoxylin and eosin, and when relevant immunohistochemical stains specific for lung cancer will be used. In case of other cancer, supplementary stains will be used according to standard regimens. Tissue is additionally sent for flow cytometry in dedicated glass tubes when lymphoma is suspected.
Diagnostic accuracy:
Diagnostic accuracy of FNA and FNB will be compared and estimated using the equation "diagnostic sample/all samples". Specimens will be evaluated according to a local modified version of the Papanicolau classification of pulmonary specimens and categorized as either:
I. Non-suitable II. Negative for malignancy III. Atypical cells (e.g. inflammatory or reactive changes) IV. Suspicious for malignancy V. Malignant
Mutational analysis:
Following tumor content evaluation of hematoxylin and eosin-stained slides, and NSCLC is concluded, relevant regions are macrodissected and subjected to a standard genomic DNA extraction procedure using the GeneRead DNA FFPE Kit (Qiagen). DNA-concentration is estimated using a Qubit Fluorometer. All methods are carried out in accordance with the manufacturer's guidelines with at least 20 % neoplastic content (estimated by pathologist) in each tissue sample. Next-Generation Sequencing (NGS) using the available NGS assay at the Department of Pathology will be performed on all NSCLC patients regardless of subtype.
The focus of the investigatior will be on the lung cancer associated biomarkers e.g. ALK, BRAF, EGFR, ERBB2, KRAS and MET.
Regarding lymphoma, analysis of tissue material will follow the normal clinical practice at the study sites, where subtyping is primarily based on immunohistochemistry and flowcytometry. The above mentioned NGS assay is performed in cases where tissue material is sparse. NGS is then necessary for classification of lymphoma subtype.
Statistics:
For the suspected lung cancer subgroup:
Sample size calculation was based on expected difference in prevalence of successful comprehensive targeted genomic profiling of 13% (77% in FNA vs 90% in core needle biopsy, CNB). With 80% power (1-beta), significance level (alpha 0.05) this yields 254 patients. It is expected that 10% (26 patients) will have other diagnoses, so the number of included participants has to be 280 patients to diagnose 127 with NSCLC in each group (FNA vs FNB).
For the suspected lymphoma subgroup:
Sample size calculation was based on expected difference in diagnostic accuracy of 31.30% with transesophageal sampling of deep-seated lymphoma (91.30% in EUS-FNB and 60% in EUS-FNA). With 90% power (1-beta) and significance level (alpha) 0.05 this yields 74 patients.
It is expected that around 10% (8 patients) will have other diagnoses, so the investigator must include 82 patients to diagnose 37 patients in each group.
Descriptive and analytical statistics will be performed using dedicated statistical software (STATA18.0; StataCorp®, Texas, US). Categorical data will be described as number (n) and percentage (%), and continuous variables as median and range. Intergroup differences in categorical variables will be analysed with Chi2-test or Fisher's test (if applicable), and differences in continuous variables with Mann-Whitney U-test.
Conditions
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Lung Cancer
Lymphoma
Sarcoidosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Participants and the department of Pathology (including NGS technicians) are blinded to needle type (FNA vs FNB needle).
Study Groups
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FNA group
Group of patients randomized to endoscopic ultrasound (EUS-B) using the standard FNA needle
Group Type
ACTIVE_COMPARATOR
FNA
Intervention Type
PROCEDURE
Endoscopic ultrasound for suspected lung cancer or lymphoma is performed to obtain tissue samples from suspected lesions with the standard FNA needle
FNB group
Group of patients randomized to endoscopic ultrasound (EUS-B) using the FNB needle
Group Type
EXPERIMENTAL
FNB
Intervention Type
PROCEDURE
Endoscopic ultrasound for suspected lung cancer or lymphoma is performed to obtain tissue samples from suspected lesions with the 3rd generation FNB needle
Interventions
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FNB
Endoscopic ultrasound for suspected lung cancer or lymphoma is performed to obtain tissue samples from suspected lesions with the 3rd generation FNB needle
Intervention Type
PROCEDURE
FNA
Endoscopic ultrasound for suspected lung cancer or lymphoma is performed to obtain tissue samples from suspected lesions with the standard FNA needle
Intervention Type
PROCEDURE
Other Intervention Names
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Fine needle biopsy
Fine needle aspiration
Eligibility Criteria
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Inclusion Criteria
* Suspicion of lung cancer or lymphoma based on chest CT or PET-CT
* Lesions adjacent to the esophagus/stomach (e.g. lung tumor, enlarged/FDG-avid lymph nodes in mediastinum or retroperitoneum, left liver lobe metastasis)
* Lesions adjacent to the esophagus/stomach (e.g. lung tumor, enlarged/FDG-avid lymph nodes in mediastinum or retroperitoneum, left liver lobe metastasis)
Exclusion Criteria
* Other previous cancer with CT or PET-CT suggesting recurrence (e.g. pulmonary metastasis)
* Uncorrected coagulopathies or anticoagulation treatment that cannot be discontinued
* Pregnant or lactating women
* CT suggesting interposed large vessels between the esophagus/stomach and target lesion
* Uncorrected coagulopathies or anticoagulation treatment that cannot be discontinued
* Pregnant or lactating women
* CT suggesting interposed large vessels between the esophagus/stomach and target lesion
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Odense University Hospital
OTHER
Sponsor Role
collaborator
Zealand University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Uffe Bodtger
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Uffe Bodtger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Zealand University Hospital, Roskilde, Denmark
Locations
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Department of Medicine, Zealand University Hospital, Næstved
Næstved, , Denmark
Site Status
Department of Respiratory Medicine, Odense University Hospital
Odense, , Denmark
Site Status
Department of Medicine, Zealand University Hospital, Roskilde
Roskilde, , Denmark
Site Status
Countries
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Denmark
References
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Yang Y, Aruna, Cheng B, Xiong D, Kuang D, Cui H, Xiong S, Mao X, Feng Y, Zhao Y. Comparison of Fine-Needle Biopsy (FNB) versus Fine-Needle Aspiration (FNA) Combined with Flow Cytometry in the Diagnosis of Deep-Seated Lymphoma. Diagnostics (Basel). 2023 Aug 28;13(17):2777. doi: 10.3390/diagnostics13172777.
Reference Type
BACKGROUND
Layfield LJ. The Papanicolaou Society of Cytopathology classification for pulmonary specimens: an overview. Cytopathology. 2016 Jun;27(3):149-52. doi: 10.1111/cyt.12344.
Reference Type
BACKGROUND
Skovgaard Christiansen I, Kuijvenhoven JC, Bodtger U, Naur TMH, Ahmad K, Singh Sidhu J, Nessar R, Salih GN, Hoegholm A, Annema JT, Clementsen PF. Endoscopic Ultrasound with Bronchoscope-Guided Fine Needle Aspiration for the Diagnosis of Paraesophageally Located Lung Lesions. Respiration. 2019;97(4):277-283. doi: 10.1159/000492578. Epub 2018 Sep 25.
Reference Type
BACKGROUND
von Bartheld MB, van Breda A, Annema JT. Complication rate of endosonography (endobronchial and endoscopic ultrasound): a systematic review. Respiration. 2014;87(4):343-51. doi: 10.1159/000357066. Epub 2014 Jan 16.
Reference Type
BACKGROUND
Skinner TR, Churton J, Edwards TP, Bashirzadeh F, Zappala C, Hundloe JT, Tan H, Pattison AJ, Todman M, Hartel GF, Fielding DI. A randomised study of comfort during bronchoscopy comparing conscious sedation and anaesthetist-controlled general anaesthesia, including the utility of bispectral index monitoring. ERJ Open Res. 2021 May 31;7(2):00895-2020. doi: 10.1183/23120541.00895-2020. eCollection 2021 Apr.
Reference Type
BACKGROUND
De S. Assessment of patient satisfaction and lidocaine requirement during flexible bronchoscopy without sedation. J Bronchology Interv Pulmonol. 2009 Jul;16(3):176-9. doi: 10.1097/LBR.0b013e3181afca25.
Reference Type
BACKGROUND
Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.
Reference Type
BACKGROUND
Karsenti D, Palazzo L, Perrot B, Zago J, Lemaistre AI, Cros J, Napoleon B. 22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy. Endoscopy. 2020 Sep;52(9):747-753. doi: 10.1055/a-1160-5485. Epub 2020 May 14.
Reference Type
BACKGROUND
Oezkan F, Byun WY, Loeffler C, Siebolts U, Diessel L, Lambrecht N, Eisenmann S. Crown-Cut Endobronchial Ultrasound Guided Transbronchial Aspiration Needle: First Real-World Experiences. J Clin Med. 2021 Dec 29;11(1):163. doi: 10.3390/jcm11010163.
Reference Type
BACKGROUND
Izumo T, Sasada S, Watanabe J, Chavez C, Matsumoto Y, Tsuchida T. Comparison of two 22 G aspiration needles for histologic sampling during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Jpn J Clin Oncol. 2014 Sep;44(9):841-5. doi: 10.1093/jjco/hyu095. Epub 2014 Jul 23.
Reference Type
BACKGROUND
Manley CJ, Kumar R, Gong Y, Huang M, Wei SS, Nagarathinam R, Haber A, Egleston B, Flieder D, Ehya H. Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology. J Am Soc Cytopathol. 2022 Mar-Apr;11(2):114-121. doi: 10.1016/j.jasc.2021.10.003. Epub 2021 Oct 23.
Reference Type
BACKGROUND
Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4.
Reference Type
BACKGROUND
Faber E, Grosu H, Sabir S, San Lucas FA, Barkoh BA, Bassett RL, Luthra R, Stewart J, Roy-Chowdhuri S. Adequacy of small biopsy and cytology specimens for comprehensive genomic profiling of patients with non-small-cell lung cancer to determine eligibility for immune checkpoint inhibitor and targeted therapy. J Clin Pathol. 2022 Sep;75(9):612-619. doi: 10.1136/jclinpath-2021-207597. Epub 2021 May 5.
Reference Type
BACKGROUND
Other Identifiers
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REG-027-2024
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE2
One Step Nucleic Acid Amplification in Endobronchial Ultrasound-guided Needle Aspiration Samples
NCT02157857
UNKNOWN
Comparison of the Diagnostic Accuracy: US-guided Percutaneous Lung Biopsies vs CT-guided in Peripheral Lung Lesions
NCT06412289
RECRUITING
NA
Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules
NCT05556525
TERMINATED
NA
Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes
NCT06921681
RECRUITING
NA
EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer
NCT00119470
COMPLETED
PHASE2
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration
NCT01774162
COMPLETED
NA
Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) Versus Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer (NSCLC)
NCT01079520
COMPLETED
NA
US NAB With ROSE Versus US FNAB With no ROSE
NCT04618874
COMPLETED
NA
EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
NCT02943837
WITHDRAWN
NA
Minimally Invasive, Diagnosis and Staging of Lung Cancer
NCT01011595
COMPLETED
NA
Endobronchial Diagnosis of Lymphoma
NCT05075655
UNKNOWN
NA
The Canada Lymph Node Score Project: A Crossover Trial
NCT04342377
COMPLETED
PHASE3
Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion
NCT02327065
UNKNOWN
NA
EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
NCT06105801
RECRUITING
PHASE3
Endobronchial Ultrasound Needle Aspiration With and Without Suction
NCT05110950
UNKNOWN
NA
Mediastinal Staging of Lung Cancer With EBUS-TBNA and EUS-B-FNA
NCT00741247
COMPLETED
NA
Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy
NCT05110131
ACTIVE_NOT_RECRUITING
NA
A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.
NCT02246322
UNKNOWN
NA
Endoscopic Ultrasound Elastography (Strain Ratio) and Fractal-based Quantitative Analysis for the Mediastinal and Abdominal Lymphadenopathies
NCT04671784
COMPLETED