SENSITIVITY OF ULTRASOUND-GUIDED 16 G CORE-NEEDLE CUTTING BIOPSY AND EXCISIONAL BIOPSY FOR THE CHARACTERIZATION OF LYMPHADENOPATHIES IN PATIENTS WITH SUSPECTED LYMPHOMA: A RANDOMIZED SUPERIORITY TRIAL
(Abstract release date: 05/19/16)
EHA Library. Pugliese N. 06/09/16; 132698; E1149
Dr. Novella Pugliese
Contributions
Contributions
Abstract
Abstract: E1149
Type: Eposter Presentation
Background
The performance of lymph node excisional biopsy requires validation. Although fine-needle aspiration under image guidance offers an alternative to open biopsies, its sensitivity in lymphoma diagnosis is still a matter of debate. New approaches to imaging-guided methods are needed. The introduction of new generation ultrasonographic devices (particularly effective in predicting the malignant status of lymphadenopathies), and progress in tissue sampling with needles with cutting edge of adequate diameter (particularly effective in providing architectural information of the core of nodal lesion) have enabled to obtain enough tissue for a definitive diagnosis (according to the WHO Classification) by mini-invasive procedures, without the need of excisional biopsy.
Aims
The primary endpoint was to demonstrate the superiority in terms of sensitivity in detecting malignancy of ultrasound (US)-guided core-needle cutting biopsy (CNCB) compared with standard excisional biopsy of lymphoadenopathies suspected for lymphoma. Secondary endpoints were: specificity, positive predictive value (PPV), negative predictive value (NPV), complication rate related to each diagnostic procedures and relative cost analysis.
Methods
From January 2009 to December 2015, in this single centre trial, patients having lymphoadenopathies with clinical suspicion of lymphoma were randomly assigned (1:1) to either US-guided CNCB or standard excisional biopsy. In the US-guided group, patients underwent baseline US exploration of all superficial lymph node areas and any abnormal lymph node underwent power-Doppler study to select the site of CNCB. The CNCB were all performed using a 16 gauge modified Menghini-type needle 150 mm in length with automatic aspiration (Biomol HS-Hospital). The selection of lymph node in the excisional biopsy (standard) group was suggested by the physical examination (at surgeon’s discretion).
Results
Overall, 372 patients were randomized into two well-matched arms. Histology showed a malignancies in 93% (172/185) of patients in the US-guided group (lymphoma, 151 patients; carcinoma, 21 patients) and in 80% (149/187) of patients in the standard group (lymphoma, 122 patients; carcinoma, 27 patients). During the follow-up of the patients with lymph nodes reported as being reactive, 19 of 38 patients in the standard group were rebiopsied and were found to have lymphoma or carcinoma at the subsequent lymph node histology, whereas three of the six patients in the US-guided group requiring a second biopsy were found to be positive for lymphoma diagnosis. Thus, sensitivity in detecting malignancy was higher in the US-guided group compared with the standard group (172/175 [98%] vs. 149/168 [89%]; p=.0003), demonstrating the superiority of US-guided CNCB in reaching a definitive histopathological diagnosis for malignancies. Biopsy provided false-negative results for malignancy in 10.2% of patients affected by lymphoma in the standard group and 1.6% in the US-guided group (p=.0005). Furthermore, US-guided CNCB showed higher NPV than traditional biopsy, 80% (12/15) vs. 50% (19/38; p=.04), respectively. No differences were found in terms of specificity and PPV between the two diagnostic techniques, by the time that no false positive were detected in both groups. Estimated cost per diagnosed with traditional biopsy was 11-fold higher compared with US-guided CNB group (p<.0001).Overall complication rate was significantly higher in patients who received excisional biopsy (78%) than in patients who underwent US-guided CNCB (15%), p<.0001.
Conclusion
US-guided CNCB has proven to be a quick, safe, and efficient technique and has radically altered the diagnostic strategy of enlarged lymph nodes at our institution, avoiding unnecessary lymph node excisions.
Session topic: E-poster
Keyword(s): Diagnosis, Lymphoid malignancy, WHO classification
Type: Eposter Presentation
Background
The performance of lymph node excisional biopsy requires validation. Although fine-needle aspiration under image guidance offers an alternative to open biopsies, its sensitivity in lymphoma diagnosis is still a matter of debate. New approaches to imaging-guided methods are needed. The introduction of new generation ultrasonographic devices (particularly effective in predicting the malignant status of lymphadenopathies), and progress in tissue sampling with needles with cutting edge of adequate diameter (particularly effective in providing architectural information of the core of nodal lesion) have enabled to obtain enough tissue for a definitive diagnosis (according to the WHO Classification) by mini-invasive procedures, without the need of excisional biopsy.
Aims
The primary endpoint was to demonstrate the superiority in terms of sensitivity in detecting malignancy of ultrasound (US)-guided core-needle cutting biopsy (CNCB) compared with standard excisional biopsy of lymphoadenopathies suspected for lymphoma. Secondary endpoints were: specificity, positive predictive value (PPV), negative predictive value (NPV), complication rate related to each diagnostic procedures and relative cost analysis.
Methods
From January 2009 to December 2015, in this single centre trial, patients having lymphoadenopathies with clinical suspicion of lymphoma were randomly assigned (1:1) to either US-guided CNCB or standard excisional biopsy. In the US-guided group, patients underwent baseline US exploration of all superficial lymph node areas and any abnormal lymph node underwent power-Doppler study to select the site of CNCB. The CNCB were all performed using a 16 gauge modified Menghini-type needle 150 mm in length with automatic aspiration (Biomol HS-Hospital). The selection of lymph node in the excisional biopsy (standard) group was suggested by the physical examination (at surgeon’s discretion).
Results
Overall, 372 patients were randomized into two well-matched arms. Histology showed a malignancies in 93% (172/185) of patients in the US-guided group (lymphoma, 151 patients; carcinoma, 21 patients) and in 80% (149/187) of patients in the standard group (lymphoma, 122 patients; carcinoma, 27 patients). During the follow-up of the patients with lymph nodes reported as being reactive, 19 of 38 patients in the standard group were rebiopsied and were found to have lymphoma or carcinoma at the subsequent lymph node histology, whereas three of the six patients in the US-guided group requiring a second biopsy were found to be positive for lymphoma diagnosis. Thus, sensitivity in detecting malignancy was higher in the US-guided group compared with the standard group (172/175 [98%] vs. 149/168 [89%]; p=.0003), demonstrating the superiority of US-guided CNCB in reaching a definitive histopathological diagnosis for malignancies. Biopsy provided false-negative results for malignancy in 10.2% of patients affected by lymphoma in the standard group and 1.6% in the US-guided group (p=.0005). Furthermore, US-guided CNCB showed higher NPV than traditional biopsy, 80% (12/15) vs. 50% (19/38; p=.04), respectively. No differences were found in terms of specificity and PPV between the two diagnostic techniques, by the time that no false positive were detected in both groups. Estimated cost per diagnosed with traditional biopsy was 11-fold higher compared with US-guided CNB group (p<.0001).Overall complication rate was significantly higher in patients who received excisional biopsy (78%) than in patients who underwent US-guided CNCB (15%), p<.0001.
Conclusion
US-guided CNCB has proven to be a quick, safe, and efficient technique and has radically altered the diagnostic strategy of enlarged lymph nodes at our institution, avoiding unnecessary lymph node excisions.
Session topic: E-poster
Keyword(s): Diagnosis, Lymphoid malignancy, WHO classification
Abstract: E1149
Type: Eposter Presentation
Background
The performance of lymph node excisional biopsy requires validation. Although fine-needle aspiration under image guidance offers an alternative to open biopsies, its sensitivity in lymphoma diagnosis is still a matter of debate. New approaches to imaging-guided methods are needed. The introduction of new generation ultrasonographic devices (particularly effective in predicting the malignant status of lymphadenopathies), and progress in tissue sampling with needles with cutting edge of adequate diameter (particularly effective in providing architectural information of the core of nodal lesion) have enabled to obtain enough tissue for a definitive diagnosis (according to the WHO Classification) by mini-invasive procedures, without the need of excisional biopsy.
Aims
The primary endpoint was to demonstrate the superiority in terms of sensitivity in detecting malignancy of ultrasound (US)-guided core-needle cutting biopsy (CNCB) compared with standard excisional biopsy of lymphoadenopathies suspected for lymphoma. Secondary endpoints were: specificity, positive predictive value (PPV), negative predictive value (NPV), complication rate related to each diagnostic procedures and relative cost analysis.
Methods
From January 2009 to December 2015, in this single centre trial, patients having lymphoadenopathies with clinical suspicion of lymphoma were randomly assigned (1:1) to either US-guided CNCB or standard excisional biopsy. In the US-guided group, patients underwent baseline US exploration of all superficial lymph node areas and any abnormal lymph node underwent power-Doppler study to select the site of CNCB. The CNCB were all performed using a 16 gauge modified Menghini-type needle 150 mm in length with automatic aspiration (Biomol HS-Hospital). The selection of lymph node in the excisional biopsy (standard) group was suggested by the physical examination (at surgeon’s discretion).
Results
Overall, 372 patients were randomized into two well-matched arms. Histology showed a malignancies in 93% (172/185) of patients in the US-guided group (lymphoma, 151 patients; carcinoma, 21 patients) and in 80% (149/187) of patients in the standard group (lymphoma, 122 patients; carcinoma, 27 patients). During the follow-up of the patients with lymph nodes reported as being reactive, 19 of 38 patients in the standard group were rebiopsied and were found to have lymphoma or carcinoma at the subsequent lymph node histology, whereas three of the six patients in the US-guided group requiring a second biopsy were found to be positive for lymphoma diagnosis. Thus, sensitivity in detecting malignancy was higher in the US-guided group compared with the standard group (172/175 [98%] vs. 149/168 [89%]; p=.0003), demonstrating the superiority of US-guided CNCB in reaching a definitive histopathological diagnosis for malignancies. Biopsy provided false-negative results for malignancy in 10.2% of patients affected by lymphoma in the standard group and 1.6% in the US-guided group (p=.0005). Furthermore, US-guided CNCB showed higher NPV than traditional biopsy, 80% (12/15) vs. 50% (19/38; p=.04), respectively. No differences were found in terms of specificity and PPV between the two diagnostic techniques, by the time that no false positive were detected in both groups. Estimated cost per diagnosed with traditional biopsy was 11-fold higher compared with US-guided CNB group (p<.0001).Overall complication rate was significantly higher in patients who received excisional biopsy (78%) than in patients who underwent US-guided CNCB (15%), p<.0001.
Conclusion
US-guided CNCB has proven to be a quick, safe, and efficient technique and has radically altered the diagnostic strategy of enlarged lymph nodes at our institution, avoiding unnecessary lymph node excisions.
Session topic: E-poster
Keyword(s): Diagnosis, Lymphoid malignancy, WHO classification
Type: Eposter Presentation
Background
The performance of lymph node excisional biopsy requires validation. Although fine-needle aspiration under image guidance offers an alternative to open biopsies, its sensitivity in lymphoma diagnosis is still a matter of debate. New approaches to imaging-guided methods are needed. The introduction of new generation ultrasonographic devices (particularly effective in predicting the malignant status of lymphadenopathies), and progress in tissue sampling with needles with cutting edge of adequate diameter (particularly effective in providing architectural information of the core of nodal lesion) have enabled to obtain enough tissue for a definitive diagnosis (according to the WHO Classification) by mini-invasive procedures, without the need of excisional biopsy.
Aims
The primary endpoint was to demonstrate the superiority in terms of sensitivity in detecting malignancy of ultrasound (US)-guided core-needle cutting biopsy (CNCB) compared with standard excisional biopsy of lymphoadenopathies suspected for lymphoma. Secondary endpoints were: specificity, positive predictive value (PPV), negative predictive value (NPV), complication rate related to each diagnostic procedures and relative cost analysis.
Methods
From January 2009 to December 2015, in this single centre trial, patients having lymphoadenopathies with clinical suspicion of lymphoma were randomly assigned (1:1) to either US-guided CNCB or standard excisional biopsy. In the US-guided group, patients underwent baseline US exploration of all superficial lymph node areas and any abnormal lymph node underwent power-Doppler study to select the site of CNCB. The CNCB were all performed using a 16 gauge modified Menghini-type needle 150 mm in length with automatic aspiration (Biomol HS-Hospital). The selection of lymph node in the excisional biopsy (standard) group was suggested by the physical examination (at surgeon’s discretion).
Results
Overall, 372 patients were randomized into two well-matched arms. Histology showed a malignancies in 93% (172/185) of patients in the US-guided group (lymphoma, 151 patients; carcinoma, 21 patients) and in 80% (149/187) of patients in the standard group (lymphoma, 122 patients; carcinoma, 27 patients). During the follow-up of the patients with lymph nodes reported as being reactive, 19 of 38 patients in the standard group were rebiopsied and were found to have lymphoma or carcinoma at the subsequent lymph node histology, whereas three of the six patients in the US-guided group requiring a second biopsy were found to be positive for lymphoma diagnosis. Thus, sensitivity in detecting malignancy was higher in the US-guided group compared with the standard group (172/175 [98%] vs. 149/168 [89%]; p=.0003), demonstrating the superiority of US-guided CNCB in reaching a definitive histopathological diagnosis for malignancies. Biopsy provided false-negative results for malignancy in 10.2% of patients affected by lymphoma in the standard group and 1.6% in the US-guided group (p=.0005). Furthermore, US-guided CNCB showed higher NPV than traditional biopsy, 80% (12/15) vs. 50% (19/38; p=.04), respectively. No differences were found in terms of specificity and PPV between the two diagnostic techniques, by the time that no false positive were detected in both groups. Estimated cost per diagnosed with traditional biopsy was 11-fold higher compared with US-guided CNB group (p<.0001).Overall complication rate was significantly higher in patients who received excisional biopsy (78%) than in patients who underwent US-guided CNCB (15%), p<.0001.
Conclusion
US-guided CNCB has proven to be a quick, safe, and efficient technique and has radically altered the diagnostic strategy of enlarged lymph nodes at our institution, avoiding unnecessary lymph node excisions.
Session topic: E-poster
Keyword(s): Diagnosis, Lymphoid malignancy, WHO classification
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