Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02884154
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2016-08-21
Brief Title:
Feasibility and Yield of a New 20 G ProCore Needle With Coiled Sheath in the Gastrointestinal Subepithelial Tumors
Sponsor:
Pusan National University Hospital
Organization:
Pusan National University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-01
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:
None
Brief Summary:
The exact incidence of subepithelial tumors SETs in the gastrointestinal GI tract is unknown but the prevalence of gastric SETs detected during routine esophagogastroduodenoscopy is 036 GI SETs may include leiomyoma GI stromal tumor GIST schwannoma lipoma cyst or ectopic pancreas Surgical resection is the principal diagnostic and therapeutic method for SETs especially for large and symptomatic ones Preoperative pathological diagnosis of SETs may facilitate clinical decision making but conventional endoscopic forceps biopsy does not yield adequate amounts of subepithelial tissue for definitive diagnosis
Although endoscopic ultrasonography EUS is the best imaging modality for the evaluation of SETs it cannot substitute histopathological diagnosis EUS-guided fine-needle aspiration EUS-FNA may provide adequate amounts of tissue for the diagnosis of SETs but it does not always afford adequate samples for immunohistochemical analysis because of the often small number of cells obtained by aspiration Since some SETs especially GI mesenchymal tumors such as GIST or schwannoma have varied morphologic appearances and diagnosis using a small biopsy is not straightforward immunohistochemical analysis is strongly advisable if not essential EUS-guided Trucut biopsy EUS-TNB may overcome the limitations of EUS-FNA in procuring sufficient core tissue specimens Although EUS-TNB is more accurate than EUS-FNA for diagnosing GI mesenchymal tumors the rigidity of its 19-gauge G caliber and the mechanical friction of the firing mechanism produced by the torqued echoendoscope limit its use for SETs located in the gastric antrum and duodenum Therefore a needle facilitating adequate histological core sampling with easy maneuverability needs to be established A 19G EUS-guided fine-needle biopsy EUS-FNB device with ProCore reverse-bevel technology was recently introduced A multicenter study revealed that histological samples could be successfully obtained using this needle in most patients having GI SETs with a diagnostic accuracy of 8010 However because of technical difficulties with this needle in the gastric antrum and duodenum the same FNB device was recently developed in a 20 G platform with coiled sheath This prospective multicenter study aimed to evaluate feasibility yield and diagnostic accuracy of a newly developed 20 G ProCore needle with coiled sheath in patients with GI SETs
Although endoscopic ultrasonography EUS is the best imaging modality for the evaluation of SETs it cannot substitute histopathological diagnosis EUS-guided fine-needle aspiration EUS-FNA may provide adequate amounts of tissue for the diagnosis of SETs but it does not always afford adequate samples for immunohistochemical analysis because of the often small number of cells obtained by aspiration Since some SETs especially GI mesenchymal tumors such as GIST or schwannoma have varied morphologic appearances and diagnosis using a small biopsy is not straightforward immunohistochemical analysis is strongly advisable if not essential EUS-guided Trucut biopsy EUS-TNB may overcome the limitations of EUS-FNA in procuring sufficient core tissue specimens Although EUS-TNB is more accurate than EUS-FNA for diagnosing GI mesenchymal tumors the rigidity of its 19-gauge G caliber and the mechanical friction of the firing mechanism produced by the torqued echoendoscope limit its use for SETs located in the gastric antrum and duodenum Therefore a needle facilitating adequate histological core sampling with easy maneuverability needs to be established A 19G EUS-guided fine-needle biopsy EUS-FNB device with ProCore reverse-bevel technology was recently introduced A multicenter study revealed that histological samples could be successfully obtained using this needle in most patients having GI SETs with a diagnostic accuracy of 8010 However because of technical difficulties with this needle in the gastric antrum and duodenum the same FNB device was recently developed in a 20 G platform with coiled sheath This prospective multicenter study aimed to evaluate feasibility yield and diagnostic accuracy of a newly developed 20 G ProCore needle with coiled sheath in patients with GI SETs
Detailed Description:
Patients and Methods
Patients with newly diagnosed GI SETs will be prospectively enrolled at 8 university hospitals in Korea between May and December 2016 if they met the following criteria having a hypoechoic mass in the submucosal andor proper muscle layers on the basis of EUS and tumor 2 cm in size Exclusion criteria are SETs were not located in the submucosal andor proper muscle layers on EUS EUS revealed the characteristic findings of lipoma cyst vessel or extraluminal lesions the platelet count was 50000mm3 and prothrombin time was 50 or the patient did not provide consent to undergo the study This study is approved by the Institutional Review Board of each hospital and conducted in accordance with the Declaration of Helsinki and its amendments and the Good Clinical Practice guidelines All enrolled patients provide written informed consents to participate in the study
Technique for EUS-FNB
All procedures are performed by using a linear array echoendoscope Olympus UCT-140 UCT-240 Olympus Tokyo Japan or PentaxEG-3870UTK Pentax Tokyo Japan with the patients placed in the left lateral decubitus position under conscious sedation
Before the study commenced all participating endosonographers discuss the procedural steps in detail Technical details of the standard tissue-acquisition protocol are as follows After the target lesion is endosonographically visualized and the region scanned for SETs using color or pulsed Doppler FNB is performed at the esophagus stomach duodenum or rectum depending on the lesion location The needle is advanced into the target tissue under endosonographic guidance
After penetrating the lesion the endosonographer moves the needle to-and-fro for more than 10 to 15 times within the lesion while an assistant simultaneously pulled out the stylet slowly and continuously over 20 s to achieve minimal negative pressure within the needle slow-pull technique Finally the needle is withdrawn from the lesion At least three needle passes are performed using the designated needle and if a diagnostic or technical failure is encountered the patient is switched to the alternative needle according to the judgment of the endosonographers
Preparation for histological analysis
Because pathologists are absent during endoscopy FNB samples are recovered and stored for subsequent processing by the endosonographers The specimens are then expressed onto slides by using a stylet or by flushing with air into the needle assembly to harvest the core samples from the needle The endosonographers then carefully inspect the material on the slides for the presence of tissue cores defined as whitish pieces of tissue with apparent bulk which are measured and then lifted off the slides and placed into a formalin bottle The core samples are macroscopically assessed as a definite tissue core suspicious tissue core mixed with blood clots or only blood or scarce sample without any tissue core The former two sample types are considered macroscopically optimal core samples
If tissue cores are obtained they are fixed in formalin and stained in hematoxylin and eosin for evaluation by pathologists Samples with tissue cores are graded as optimal or suboptimal optimal if the material allows satisfactory assessment of histologic architecture and immunohistochemical evaluation such as c-kit CD34 S-100 or smooth muscle actin if indicated and suboptimal if the histological core is inadequate for the abovementioned assessments Because the morphological characteristics of mesenchymal tumors are nonspecific a positive diagnosis by EUS-FNB is only considered true positive when immunohistochemical analysis is conclusive Conventional cytological analysis is additionally performed in most cases or if a core sample is unavailable Cytological material is sent to the cytologists as a fixed or an air-dried slide The gold standard is the histopathological assessment of the resected specimens for patients who underwent endoscopic resection or surgery and the assessment of the FNB samples for those who did not
Outcome parameters
The primary outcome parameter is diagnostic sufficiency Diagnostic sufficiency is defined as the proportion of patients in whom the histopathological diagnosis could be established within three needle passes The percentage of cases in which the pathologist classified the quality of the sample as optimal for histological evaluation is also evaluated The secondary outcome measures are rates of diagnostic failure technical failure and complications Diagnostic failure is defined as failure to obtain sufficient core samples even after three passes and technical failure is defined as malfunction of the needle before three needle passes Complications are defined as any deviation from the clinical course after EUS-guided sampling as observed by the endosonographers or recovery suite nurses or as reported by patients Excessive bleeding at the site of puncture perforation hypotension and need for reversal medication are documented
Patients with newly diagnosed GI SETs will be prospectively enrolled at 8 university hospitals in Korea between May and December 2016 if they met the following criteria having a hypoechoic mass in the submucosal andor proper muscle layers on the basis of EUS and tumor 2 cm in size Exclusion criteria are SETs were not located in the submucosal andor proper muscle layers on EUS EUS revealed the characteristic findings of lipoma cyst vessel or extraluminal lesions the platelet count was 50000mm3 and prothrombin time was 50 or the patient did not provide consent to undergo the study This study is approved by the Institutional Review Board of each hospital and conducted in accordance with the Declaration of Helsinki and its amendments and the Good Clinical Practice guidelines All enrolled patients provide written informed consents to participate in the study
Technique for EUS-FNB
All procedures are performed by using a linear array echoendoscope Olympus UCT-140 UCT-240 Olympus Tokyo Japan or PentaxEG-3870UTK Pentax Tokyo Japan with the patients placed in the left lateral decubitus position under conscious sedation
Before the study commenced all participating endosonographers discuss the procedural steps in detail Technical details of the standard tissue-acquisition protocol are as follows After the target lesion is endosonographically visualized and the region scanned for SETs using color or pulsed Doppler FNB is performed at the esophagus stomach duodenum or rectum depending on the lesion location The needle is advanced into the target tissue under endosonographic guidance
After penetrating the lesion the endosonographer moves the needle to-and-fro for more than 10 to 15 times within the lesion while an assistant simultaneously pulled out the stylet slowly and continuously over 20 s to achieve minimal negative pressure within the needle slow-pull technique Finally the needle is withdrawn from the lesion At least three needle passes are performed using the designated needle and if a diagnostic or technical failure is encountered the patient is switched to the alternative needle according to the judgment of the endosonographers
Preparation for histological analysis
Because pathologists are absent during endoscopy FNB samples are recovered and stored for subsequent processing by the endosonographers The specimens are then expressed onto slides by using a stylet or by flushing with air into the needle assembly to harvest the core samples from the needle The endosonographers then carefully inspect the material on the slides for the presence of tissue cores defined as whitish pieces of tissue with apparent bulk which are measured and then lifted off the slides and placed into a formalin bottle The core samples are macroscopically assessed as a definite tissue core suspicious tissue core mixed with blood clots or only blood or scarce sample without any tissue core The former two sample types are considered macroscopically optimal core samples
If tissue cores are obtained they are fixed in formalin and stained in hematoxylin and eosin for evaluation by pathologists Samples with tissue cores are graded as optimal or suboptimal optimal if the material allows satisfactory assessment of histologic architecture and immunohistochemical evaluation such as c-kit CD34 S-100 or smooth muscle actin if indicated and suboptimal if the histological core is inadequate for the abovementioned assessments Because the morphological characteristics of mesenchymal tumors are nonspecific a positive diagnosis by EUS-FNB is only considered true positive when immunohistochemical analysis is conclusive Conventional cytological analysis is additionally performed in most cases or if a core sample is unavailable Cytological material is sent to the cytologists as a fixed or an air-dried slide The gold standard is the histopathological assessment of the resected specimens for patients who underwent endoscopic resection or surgery and the assessment of the FNB samples for those who did not
Outcome parameters
The primary outcome parameter is diagnostic sufficiency Diagnostic sufficiency is defined as the proportion of patients in whom the histopathological diagnosis could be established within three needle passes The percentage of cases in which the pathologist classified the quality of the sample as optimal for histological evaluation is also evaluated The secondary outcome measures are rates of diagnostic failure technical failure and complications Diagnostic failure is defined as failure to obtain sufficient core samples even after three passes and technical failure is defined as malfunction of the needle before three needle passes Complications are defined as any deviation from the clinical course after EUS-guided sampling as observed by the endosonographers or recovery suite nurses or as reported by patients Excessive bleeding at the site of puncture perforation hypotension and need for reversal medication are documented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None