Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412289
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-29
Brief Title:
Comparison of the Diagnostic Accuracy Between US-guided Percutaneous Lung Biopsies vs CT-guided in Peripheral Lung Lesions
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
A Prospective Randomized Multicentric and Single-blinded Study on Accuracy and Safety of Ultrasound US Guided Percutaneous Needle Biopsy of Peripheral Lung Lesion Compared With Computed TomogrAphy CT Guided Needle Biopsy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SULTAN
Brief Summary:
A non-sponsored prospective randomized single-blind national multicenter interventional study which aims to compare the diagnostic accuracy between US-guided percutaneous lung needle biopsies and CT-guided in peripheral lung lesions Secondary endpoints are
onset of number and type of complications during and after the procedure within the first three hour
exposition to ionizing radiation in mGy
patient comfort during the procedure
duration of the procedure
onset of number and type of complications during and after the procedure within the first three hour
exposition to ionizing radiation in mGy
patient comfort during the procedure
duration of the procedure
Detailed Description:
Peripherical pulmonary lesions without endobronchial lesions LPP are nowadays more and more frequently found in clinical practice and its only assumable that this tendency will keep growing in the future alongside the increasing use of thoracic CT scanning and the proven efficacy in lung cancer screening Even though most of these lesions are benign its still important to be able to identify neoplastic lesions in an early stage
The gold standard for diagnosis definition is biopsy which can be performed by four paths surgery transbronchial endoscopy TBB endobronchial endoscopy EBB or percutaneous TTNA
Surgical option is the most reliable one in terms of diagnostic yield at the expense of an increased risk of complications post-operative recovery in hospital staying and costs compared with the other three procedures due to the safety and diagnostic yield of TBB EBB and TTNA the surgical approach just for the purpose of diagnosis resulted in a secondary choice in the diagnostic flowchart of LPP In addiction given the high probability of the benign nature of the LPP the choice of a less invasive approach in the diagnostic phase is even more reasonable Even though technology really improved the diagnostic yield of LPP overall sensibility is around 70-80 influenced by many factors such as localization and extension of the lesion presence of bronchus sign sampling techniques and procedural errors The incidence of complications for this type of sampling mostly presented by pneumothorax is around 4
The TTNA is a largely used procedure for diagnosing LPP and it can be conducted using both a CT guided and an ultrasound guided approach as long as the lesion is located in direct contact with the thoracic wall CT scan guide has the perk of giving a more precise view of densitometric feature of the lesions their location and the connections with the anatomical structures surrounding them LPP CT guided TTNA tTTNA can reach a diagnostic yield of 98 in case of an experienced operator where ultrasound guided reaches about 934 only slightly inferior to the prior one Both tTTNA and ultrasound guided percutaneous transthoracic biopsy eTTNA are useful techniques not only for pulmonary parenchymal diseases but also in case of pleural lesions allowing simultaneous sampling and visualization of the lesions in exam
Peripheric pleural lesions can also be approached via thoracoscopy both medical and surgical with a diagnostic efficiency between 91-95 for malignant lesions and 100 for TBC-related lesions However the high risk of complications after the procedure the duration of hospitalization post-surgery and the costs suggest choosing between eTTNA and tTTNA as the very first diagnostic step in pleural lesions as well Moreover the diagnostic yield of tTTNA and eTTNA is respectively of 89 and 90
Both eTTNA and tTTNA demonstrated a good ability in distinguishing between benign and malignant lesions In the latter case collecting a representative enough sample allows the appropriate immunohistochemical phenotyping and genetic sequencing of it enabling to make targeted therapeutical choices according to the current Guidelines
Literature suggests that the number of bioptic steps necessary to obtain an adequate diagnostic sample is of three steps where an upper number of them would increase the risk of complications despite an almost equal diagnostic efficiency Principal complications of percutaneous sampling common to both the approaches are pneumothorax and minor bleeding not requiring blood transfusion In literature there are no clear indications about which of these two methods is better in case of lesions touching the pleural surface therefore approachable with both tTTNA and eTTNA in everyday clinical practice the choice is mostly driven by the availability of each technique in the Center of expertise Also from the literature that could be gathered there is no prospective comparison between ultrasound-guided and CT-guided needle biopsy of peripheric pulmonary lesion touching the thoracic wall
Nonetheless a trial retrospectively analyzed both ultrasound-guided and CT-guided sampling of thoracic lesions touching the wall and it enlighted that the complications rate was minor for the ultrasound-guided approach respectively 33 and 24 Even more differently from the tTTNA eTTNA doesnt expose the patients to any ionizing radiation and it allows to avoid artefacts deriving from respiratory movements and the ribs interposition
On this ground of observations we present the following trial which would be the first prospective one to compare the diagnostic accuracy between the two approaches tTTNA and eTTNA for diagnosing peripheric pulmonary lesions touching the thoracic wall
The trials goal is comparing the diagnostic yield of ultrasound-guided vs CT-guided histological sampling of peripheric pulmonary lesions touching the thoracic wall
All patients must therefore have carried out recent blood tests within one month before the procedure routine including complete blood count INR aPTT PT
When taking charge of the patient the inclusion and exclusion criteria will be verified The patient candidate for the procedure signs the informed consent to the study in the presence of the local coordinator or co-investigator The coordinator or co-investigator will proceed with the randomization through random numbers generated by a computer to perform ultrasound-guided or CT-guided sampling which will be scheduled with the usual technical times of each individual participating Center
Each patient will be assigned a progressive numbercode for anonymization purposes to be used in the eCRF The diagnostic procedures will be carried out in the Respiratory Endoscopy and Radiology rooms where TTNAs are usually carried out The ultrasound investigation will be conducted usings the ultrasound machine supplied to the Center involved in the trial and usually used in eTTNA procedures
The CT scan will be performed using the CT machinery equipped by the Center involved in the trial and usually used for the tTTNA procedures
Before the procedure the vital signs of the patient will be noted and each operator will choose the most appropriate position for the sampling based on the location of the lesion The thoracic area to biopsy will then be defined and then there will be the setting of the sterile field In accordance to the guide-lines the patient should not be sedated if possible At this point local anesthesia with a maximum of 20ml of 2 lidocaine will be administrated marking down this time as the time of the beginning of the procedure
18G needles will be used to collect the samples since this size allows a good balancing between risk of complication and diagnostic yield For each patient there will be collected a minumum number of one and a maximum number of three bioptic sampling The sample will be stored and preserved inside specific containers to allow optimal transfer to the Pathology laboratories based on the directions of the laboratory itself and the usual procedure of the involved Center
Once the procedure is done the patient will remain in the involved Center for a period of observation of at least three hours During this time the patient will be monitored through vital signs and the occurrence of any complication After one hour from the procedure a thoracic X-Ray examination will be taken preferably in orthostatism in both inhale and exhale The management of any possible complication will be carried out as part the singular Centers practice in agreement with the latest Guide Lines regarding the matter
In the case of the impossibility of the technical use of the procedure assign to the singular patient by the randomization the patient will be excluded from the trial and will carry on the diagnostic iter according to the usual clinical practices
The onset of complications will be registered during the patients monitoring process which will last for the three hours following the procedure All the participant patients will be informed about the possible late-onset complications after the procedure and about the necessity of coming back to the hospital in case of the occurrence of any symptoms such as dyspnea chest pain hemoptysishemosputum
The anatomopathologist will receive the samples without the indication of the methodic used for the biopsy The pathologist will then pronounce judgment un 1 adequacy of the samples for the purpose of the diagnosis 2 where indicated the suitability for a full histological molecular analysis Once the diagnosis is given the local coordinator or the co-investigators will communicate the result to the patient as soon as possible in order to address the patient to the currently most appropriated diagnostic-therapeutic pathway
The tissue sample will be submitted to the pathologist along with a form containing personal data anamnesis clinical suspicion the sample topography and the trial code In order to preserve the double-blind criteria in the anatomopathological reporting all the requests coming from a center will submitted after the name of the local coordinator The pathologist will report the resulting diagnosis to his centers the coordinator via email and only then it will be possible to move forward to the unblinding Enrolled patients will be entered in an eCRF file shared exclusively between the interventional operators Therefore the patients will be addressed to the best diagnostic-therapeutic program available at the time according to the most recent guidelines
The gold standard for diagnosis definition is biopsy which can be performed by four paths surgery transbronchial endoscopy TBB endobronchial endoscopy EBB or percutaneous TTNA
Surgical option is the most reliable one in terms of diagnostic yield at the expense of an increased risk of complications post-operative recovery in hospital staying and costs compared with the other three procedures due to the safety and diagnostic yield of TBB EBB and TTNA the surgical approach just for the purpose of diagnosis resulted in a secondary choice in the diagnostic flowchart of LPP In addiction given the high probability of the benign nature of the LPP the choice of a less invasive approach in the diagnostic phase is even more reasonable Even though technology really improved the diagnostic yield of LPP overall sensibility is around 70-80 influenced by many factors such as localization and extension of the lesion presence of bronchus sign sampling techniques and procedural errors The incidence of complications for this type of sampling mostly presented by pneumothorax is around 4
The TTNA is a largely used procedure for diagnosing LPP and it can be conducted using both a CT guided and an ultrasound guided approach as long as the lesion is located in direct contact with the thoracic wall CT scan guide has the perk of giving a more precise view of densitometric feature of the lesions their location and the connections with the anatomical structures surrounding them LPP CT guided TTNA tTTNA can reach a diagnostic yield of 98 in case of an experienced operator where ultrasound guided reaches about 934 only slightly inferior to the prior one Both tTTNA and ultrasound guided percutaneous transthoracic biopsy eTTNA are useful techniques not only for pulmonary parenchymal diseases but also in case of pleural lesions allowing simultaneous sampling and visualization of the lesions in exam
Peripheric pleural lesions can also be approached via thoracoscopy both medical and surgical with a diagnostic efficiency between 91-95 for malignant lesions and 100 for TBC-related lesions However the high risk of complications after the procedure the duration of hospitalization post-surgery and the costs suggest choosing between eTTNA and tTTNA as the very first diagnostic step in pleural lesions as well Moreover the diagnostic yield of tTTNA and eTTNA is respectively of 89 and 90
Both eTTNA and tTTNA demonstrated a good ability in distinguishing between benign and malignant lesions In the latter case collecting a representative enough sample allows the appropriate immunohistochemical phenotyping and genetic sequencing of it enabling to make targeted therapeutical choices according to the current Guidelines
Literature suggests that the number of bioptic steps necessary to obtain an adequate diagnostic sample is of three steps where an upper number of them would increase the risk of complications despite an almost equal diagnostic efficiency Principal complications of percutaneous sampling common to both the approaches are pneumothorax and minor bleeding not requiring blood transfusion In literature there are no clear indications about which of these two methods is better in case of lesions touching the pleural surface therefore approachable with both tTTNA and eTTNA in everyday clinical practice the choice is mostly driven by the availability of each technique in the Center of expertise Also from the literature that could be gathered there is no prospective comparison between ultrasound-guided and CT-guided needle biopsy of peripheric pulmonary lesion touching the thoracic wall
Nonetheless a trial retrospectively analyzed both ultrasound-guided and CT-guided sampling of thoracic lesions touching the wall and it enlighted that the complications rate was minor for the ultrasound-guided approach respectively 33 and 24 Even more differently from the tTTNA eTTNA doesnt expose the patients to any ionizing radiation and it allows to avoid artefacts deriving from respiratory movements and the ribs interposition
On this ground of observations we present the following trial which would be the first prospective one to compare the diagnostic accuracy between the two approaches tTTNA and eTTNA for diagnosing peripheric pulmonary lesions touching the thoracic wall
The trials goal is comparing the diagnostic yield of ultrasound-guided vs CT-guided histological sampling of peripheric pulmonary lesions touching the thoracic wall
All patients must therefore have carried out recent blood tests within one month before the procedure routine including complete blood count INR aPTT PT
When taking charge of the patient the inclusion and exclusion criteria will be verified The patient candidate for the procedure signs the informed consent to the study in the presence of the local coordinator or co-investigator The coordinator or co-investigator will proceed with the randomization through random numbers generated by a computer to perform ultrasound-guided or CT-guided sampling which will be scheduled with the usual technical times of each individual participating Center
Each patient will be assigned a progressive numbercode for anonymization purposes to be used in the eCRF The diagnostic procedures will be carried out in the Respiratory Endoscopy and Radiology rooms where TTNAs are usually carried out The ultrasound investigation will be conducted usings the ultrasound machine supplied to the Center involved in the trial and usually used in eTTNA procedures
The CT scan will be performed using the CT machinery equipped by the Center involved in the trial and usually used for the tTTNA procedures
Before the procedure the vital signs of the patient will be noted and each operator will choose the most appropriate position for the sampling based on the location of the lesion The thoracic area to biopsy will then be defined and then there will be the setting of the sterile field In accordance to the guide-lines the patient should not be sedated if possible At this point local anesthesia with a maximum of 20ml of 2 lidocaine will be administrated marking down this time as the time of the beginning of the procedure
18G needles will be used to collect the samples since this size allows a good balancing between risk of complication and diagnostic yield For each patient there will be collected a minumum number of one and a maximum number of three bioptic sampling The sample will be stored and preserved inside specific containers to allow optimal transfer to the Pathology laboratories based on the directions of the laboratory itself and the usual procedure of the involved Center
Once the procedure is done the patient will remain in the involved Center for a period of observation of at least three hours During this time the patient will be monitored through vital signs and the occurrence of any complication After one hour from the procedure a thoracic X-Ray examination will be taken preferably in orthostatism in both inhale and exhale The management of any possible complication will be carried out as part the singular Centers practice in agreement with the latest Guide Lines regarding the matter
In the case of the impossibility of the technical use of the procedure assign to the singular patient by the randomization the patient will be excluded from the trial and will carry on the diagnostic iter according to the usual clinical practices
The onset of complications will be registered during the patients monitoring process which will last for the three hours following the procedure All the participant patients will be informed about the possible late-onset complications after the procedure and about the necessity of coming back to the hospital in case of the occurrence of any symptoms such as dyspnea chest pain hemoptysishemosputum
The anatomopathologist will receive the samples without the indication of the methodic used for the biopsy The pathologist will then pronounce judgment un 1 adequacy of the samples for the purpose of the diagnosis 2 where indicated the suitability for a full histological molecular analysis Once the diagnosis is given the local coordinator or the co-investigators will communicate the result to the patient as soon as possible in order to address the patient to the currently most appropriated diagnostic-therapeutic pathway
The tissue sample will be submitted to the pathologist along with a form containing personal data anamnesis clinical suspicion the sample topography and the trial code In order to preserve the double-blind criteria in the anatomopathological reporting all the requests coming from a center will submitted after the name of the local coordinator The pathologist will report the resulting diagnosis to his centers the coordinator via email and only then it will be possible to move forward to the unblinding Enrolled patients will be entered in an eCRF file shared exclusively between the interventional operators Therefore the patients will be addressed to the best diagnostic-therapeutic program available at the time according to the most recent guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None