LymphadenopathyNCT01384357
Ultrasound-Guided Needle Biopsy in the Diagnosis of Malignant Cervical Lymphadenopathies
An observational study of Lymphadenopathy and Malignancy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The objective of the present study was to compare ultrasound (US) characteristics and ultrasound-guided core-needle biopsy (US-CNB) with US-guided fine-needle aspiration (US-FNA) in the assessment of different malignant cervical lymphadenopathies. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Lymphadenopathy, Malignancy
- How many people
- 116 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July to 2010 Dec were retrospectively reviewed. There are two major study groups according to the treatment status of the patient's population, including patients who had pathology proofed previous cancer and with clinically cervical lymphadenopathies after treatment. The second group included patients with cervical lymphaenopathies but without previous diagnosis of malignancy and treatment.
Who may be able to join
- Patients with malignant cervical lymphadenopathie With US-FNA or US-CNB evaluation before
Who cannot join
- No ultrasound exam
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Otolaryngology, Far Eastern Memorial Hospital
Taipei
About this study
Official title: Real-time Ultrasound-Guided Needle Biopsy in the Diagnosis of Malignant Cervical Lymphadenopathies
The objective of the present study was to compare ultrasound (US) characteristics and ultrasound-guided core-needle biopsy (US-CNB) with US-guided fine-needle aspiration (US-FNA) in the assessment of different malignant cervical lymphadenopathies. Patients with malignant cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July to 2010 Dec were retrospectively reviewed. There are two major study groups according to the treatment status of the patient's population, including patients who had pathology proofed previous cancer and with clinically cervical lymphadenopathies after treatment. The second group included patients with cervical lymphaenopathies but without previous diagnosis of malignancy and treatment. The results of cytology, or pathology and time of needle biopsy to final diagnosis were traced and recorded. Morphologic US parameters and vascular features were thoroughly evaluated and compared in different disease.
Read the detailed description
Introduction
In the absence of infection signs, lateral neck lymphadenopathies should be suspected as metastatic carcinoma or lymphoma until proved otherwise. Previously, the most commonly used sampling techniques in the head and neck are the open excisional biopsy and fine-needle aspiration (FNA) cytology. Open biopsy and lymph node excision provides material suitable for histological analysis but is invasive and may entail general anesthesia and hospital admission. Besides, excisional and incisional biopsy of cervical metastases results in a 2-3 times increased incidence of local treatment failure when compared with FNA cytology.
High-resolution ultrasound is widely used imaging modality to evaluate the morphology, internal architecture, size and shape of cervical lymph nodes. In the head and neck, the image guidance technique most commonly used has been ultrasound. The real-time capability and ease of use makes ultrasound the procedure of choice. The evidence of improved efficacy of ultrasound-guided FNA over palpation-guided FNA in the head and neck also has been well documented, leading to its acceptance as the standard procedure.
Disadvantages of FNA include a high rate of nondiagnostic samples and incomplete classification of lymphoma with delayed diagnosis. The core-needle biopsy (CNB) is an alternative to the established ways of tissue sampling and used very successfully for many years. As the histologic architecture of the lesion is preserved, it provides a sample that is adequate for histopathologic and immunohistochemical examination.
To our knowledge, there was only one prospective investigation comparing ultrasound guided CNB with FNA in the head and neck region. However, the studied population was heterogeneous and case numbers were limited. The result revealed no significant difference between both methods. The objective of the present study was to compare ultrasound-guided CNB with FNA in the assessment of different malignant cervical lymphadenopathies.
Patients and methods
A retrospective study will be performed including consecutive patients over a 3-year period from 2007 July to 2010 Dec. All patients were seen at our institution with malignant cervical lymphadenopathies. The biopsies were performed on an outpatient basis, unless the patient was hospitalized for alternative reasons. Equipment for sonographic studies consisted of a color Doppler US unit (Philips HDI 5000, Bothell, WA, US) and a 5-12 MHz broadband linear array transducer.
Morphologic US parameters and vascular features were thoroughly evaluated and recorded on the PACS system (Marotech Inc, Seoul, South Korea) for the largest nodal lesion in each patient. Every lymph node was assessed first with gray-scale sonography for morphologic parameters in horizontal and then longitudinal sections. The short-axis diameter, long-axis diameter and diameter ratio of short to long axis (S/L ratio) were measured. Echogenicity with respect to the surrounding soft tissue was assessed and classified as hypoechoic, isoechoic, or hyperechoic. Lymph node margin was defined as regular or irregular. Echogenic hilus was distinguished between its presence or absence. Internal echo pattern was divided into heterogeneity or homogeneity. Vascular patterns were then surveyed by power Doppler sonography and categorized as the group of avascular or hilar type versus that of mixed, spotted, or peripheral type.
With the data on history, physical examination, and ultrasound result, we decided that ultrasound guided needle biopsies would be the first line of investigation for these lesions. Informed consent for the procedure was obtained from all the patients before biopsy. In general, FNA was carried out with the array probe guiding the placement of a 22-gauge fine needle within the largest node after sterilization without anesthesia. For CNB, the skin was sterilized and locally anaesthetized with 2% lidocaine. A modified non-advancing, disposable, spring-loaded cutting biopsy needle (Temno biopsy system, Allegiance Healthcare Corporation, McGaw Park, IL, USA) with 15-mm side-notch of 9 cm length and 18-gauge were used. All biopsies were done by the same experienced otolaryngologist (Li-Jen Liao) under real-time ultrasound guidance with freehand technique. Three times of tissue core biopsies were done for each patient. After the biopsy, all patients were asked to compress the puncture site and were evaluated for possible complications such as bleeding or bruising for half an hour before leaving the examination room.
The specimens were put in 10% formalin solution for pathologic studies. In the Department of Pathology, formalin-fixed, paraffin-embeddedm sections from the biopsies were stained with hematoxylin and eosin for morphologic examination. Further immunohistochemical studies were performed as necessary.
There are two major study groups according to the treatment status of the patient's population. The first group included patients who had pathology proofed previous cancer and with clinically cervical lymphadenopathies after treatment. The second group included patients with cervical lymphaenopathies but without previous diagnosis of malignancy and treatment. The disease groups were further classified as metastatic nodes from nonthyroid primary (META), lymphoma (LYM) and metastatic nodes from papillary carcinoma of the thyroid (PAP).
The results of cytology and pathology were graded as false negative, suspicious and positive for malignancy. The final diagnoses of patients were established by the histopathology. The time of needle biopsy and final diagnosis were traced and recorded.
Statistically, continuous variables were compared by performing the Kruskal-Wallis test. Category data were compared by using the Chi-square test or Fisher's exact test. The time from procedure to final diagnosis were expressed in K-M plot and tested with Log-rank test. All statistical analyses were accomplished using SAS software, version 9.1 (SAS Institute, Inc, Cary, North Carolina).
Expected Results:
We will know the differential US characteristics in different malignant cervical lymphadenopathies. Besides, we will know US-FNA or US-CNB is preferred in which situation.
- Conditions
- Lymphadenopathy, Malignancy
- Keywords
- lymphadenopathy, needle biopsy, sonography
- Medical subject headings
- Lymphadenopathy, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound,lymphadenopathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of needle biopsy to final diagnosis
Measured: days from needle biopsy to final diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphadenopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Li-Jen Liao, M.D., Principal investigator, Department of Otolaryngology, Far Eastern Memorial Hospital, New Taipei City, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384357
- Sponsor's protocol ID
- 100026-E
- Status last verified
- May 2011
- First submitted
- 27 Jun 2011
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Ultrasound-Guided Needle Biopsy in the Diagnosis of Malignant Cervical Lymphadenopathies
- ClinicalTrials.gov ID
- NCT01384357
- Acronym / sponsor ID
- 100026-E
- Conditions
- Lymphadenopathy, Malignancy
- Keywords
- lymphadenopathy, needle biopsy, sonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present study was to compare ultrasound (US) characteristics and ultrasound-guided core-needle biopsy (US-CNB) with US-guided fine-needle aspiration (US-FNA) in the assessment of different malignant cervical lymphadenopathies. Patients with malignant cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July to 2010 Dec were retrospectively reviewed. There are two major study groups according to the treatment status of the patient's population, including patients who had pathology proofed previous cancer and with clinically cervical lymphadenopathies after treatment. The second group included patients with cervical lymphaenopathies but without previous diagnosis of malignancy and treatment. The results of cytology, or pathology and time of needle biopsy to final diagnosis were traced and recorded. Morphologic US parameters and vascular features were thoroughly evaluated and compared in different disease.
Detailed description
Introduction
In the absence of infection signs, lateral neck lymphadenopathies should be suspected as metastatic carcinoma or lymphoma until proved otherwise. Previously, the most commonly used sampling techniques in the head and neck are the open excisional biopsy and fine-needle aspiration (FNA) cytology. Open biopsy and lymph node excision provides material suitable for histological analysis but is invasive and may entail general anesthesia and hospital admission. Besides, excisional and incisional biopsy of cervical metastases results in a 2-3 times increased incidence of local treatment failure when compared with FNA cytology.
High-resolution ultrasound is widely used imaging modality to evaluate the morphology, internal architecture, size and shape of cervical lymph nodes. In the head and neck, the image guidance technique most commonly used has been ultrasound. The real-time capability and ease of use makes ultrasound the procedure of choice. The evidence of improved efficacy of ultrasound-guided FNA over palpation-guided FNA in the head and neck also has been well documented, leading to its acceptance as the standard procedure.
Disadvantages of FNA include a high rate of nondiagnostic samples and incomplete classification of lymphoma with delayed diagnosis. The core-needle biopsy (CNB) is an alternative to the established ways of tissue sampling and used very successfully for many years. As the histologic architecture of the lesion is preserved, it provides a sample that is adequate for histopathologic and immunohistochemical examination.
To our knowledge, there was only one prospective investigation comparing ultrasound guided CNB with FNA in the head and neck region. However, the studied population was heterogeneous and case numbers were limited. The result revealed no significant difference between both methods. The objective of the present study was to compare ultrasound-guided CNB with FNA in the assessment of different malignant cervical lymphadenopathies.
Patients and methods
A retrospective study will be performed including consecutive patients over a 3-year period from 2007 July to 2010 Dec. All patients were seen at our institution with malignant cervical lymphadenopathies. The biopsies were performed on an outpatient basis, unless the patient was hospitalized for alternative reasons. Equipment for sonographic studies consisted of a color Doppler US unit (Philips HDI 5000, Bothell, WA, US) and a 5-12 MHz broadband linear array transducer.
Morphologic US parameters and vascular features were thoroughly evaluated and recorded on the PACS system (Marotech Inc, Seoul, South Korea) for the largest nodal lesion in each patient. Every lymph node was assessed first with gray-scale sonography for morphologic parameters in horizontal and then longitudinal sections. The short-axis diameter, long-axis diameter and diameter ratio of short to long axis (S/L ratio) were measured. Echogenicity with respect to the surrounding soft tissue was assessed and classified as hypoechoic, isoechoic, or hyperechoic. Lymph node margin was defined as regular or irregular. Echogenic hilus was distinguished between its presence or absence. Internal echo pattern was divided into heterogeneity or homogeneity. Vascular patterns were then surveyed by power Doppler sonography and categorized as the group of avascular or hilar type versus that of mixed, spotted, or peripheral type.
With the data on history, physical examination, and ultrasound result, we decided that ultrasound guided needle biopsies would be the first line of investigation for these lesions. Informed consent for the procedure was obtained from all the patients before biopsy. In general, FNA was carried out with the array probe guiding the placement of a 22-gauge fine needle within the largest node after sterilization without anesthesia. For CNB, the skin was sterilized and locally anaesthetized with 2% lidocaine. A modified non-advancing, disposable, spring-loaded cutting biopsy needle (Temno biopsy system, Allegiance Healthcare Corporation, McGaw Park, IL, USA) with 15-mm side-notch of 9 cm length and 18-gauge were used. All biopsies were done by the same experienced otolaryngologist (Li-Jen Liao) under real-time ultrasound guidance with freehand technique. Three times of tissue core biopsies were done for each patient. After the biopsy, all patients were asked to compress the puncture site and were evaluated for possible complications such as bleeding or bruising for half an hour before leaving the examination room.
The specimens were put in 10% formalin solution for pathologic studies. In the Department of Pathology, formalin-fixed, paraffin-embeddedm sections from the biopsies were stained with hematoxylin and eosin for morphologic examination. Further immunohistochemical studies were performed as necessary.
There are two major study groups according to the treatment status of the patient's population. The first group included patients who had pathology proofed previous cancer and with clinically cervical lymphadenopathies after treatment. The second group included patients with cervical lymphaenopathies but without previous diagnosis of malignancy and treatment. The disease groups were further classified as metastatic nodes from nonthyroid primary (META), lymphoma (LYM) and metastatic nodes from papillary carcinoma of the thyroid (PAP).
The results of cytology and pathology were graded as false negative, suspicious and positive for malignancy. The final diagnoses of patients were established by the histopathology. The time of needle biopsy and final diagnosis were traced and recorded.
Statistically, continuous variables were compared by performing the Kruskal-Wallis test. Category data were compared by using the Chi-square test or Fisher's exact test. The time from procedure to final diagnosis were expressed in K-M plot and tested with Log-rank test. All statistical analyses were accomplished using SAS software, version 9.1 (SAS Institute, Inc, Cary, North Carolina).
Expected Results:
We will know the differential US characteristics in different malignant cervical lymphadenopathies. Besides, we will know US-FNA or US-CNB is preferred in which situation.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound,lymphadenopathy | – | – |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July to 2010 Dec were retrospectively reviewed. There are two major study groups according to the treatment status of the patient's population, including patients who had pathology proofed previous cancer and with clinically cervical lymphadenopathies after treatment. The second group included patients with cervical lymphaenopathies but without previous diagnosis of malignancy and treatment.
Key inclusion criteria (1 listed)
- Patients with malignant cervical lymphadenopathie With US-FNA or US-CNB evaluation before
Key exclusion criteria (1 listed)
- No ultrasound exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time of needle biopsy to final diagnosis
Time frame: days from needle biopsy to final diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Jen Liao, M.D. principal investigator
Department of Otolaryngology, Far Eastern Memorial Hospital, New Taipei City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphadenopathy and Malignancy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of needle biopsy to final diagnosis (time frame: days from needle biopsy to final diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.