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This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.
A 19 gauge needle in nitinol (Flex needle) has been recently become available for EUS guided procedure.
The use of nitinol should guarantee a better needle flexibility with a theoretical advantage on the use of this needle for lesions that need to be sampled through the duodenum. Moreover, samples for histologic examination seems to be easy to interpret than cytologic ones allowing evaluate of the overall architecture of the tissue, better performance of immunohistochemical staining, and may be of additional value to perform tissue profiling that in the future will be very important to guide individualized therapies
The existing data on the performance of the Flex needle for EUS-guided transduodenal biopsy are coming form a single study performed in one single center. Thus, the reproducibility of these results is unknown and multicenter prospective studies are warranted to answer this important question.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with solid lesions | Experimental | Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) | Device | EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion | Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Complications Divided Per Total Number of Enrolled Patients | rate of complications, divided in procedural complication (perforation, bleeding) occurring during the procedure and late complications (delayed bleeding, infection) occurring during the post-procedural observational period | intraoperative and within 3 days after the procedure |
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Inclusion Criteria:
A. Age greater than 18 and less than 90. B. Presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis.
C. Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
D. Informed consent is obtained.
Exclusion Criteria:
A. Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
B. Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.
C. They are unable to understand and/or read the consent form.
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| Name | Affiliation | Role |
|---|---|---|
| Guido Costamagna, MD | Catholic University of the Sacred Heart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Univerisity Health Medical Center | Indianapolis | Indiana | 46202 | United States | ||
| Clinique du Trocadero |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22817786 | Result | Varadarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc. 2012 Aug;76(2):336-43. doi: 10.1016/j.gie.2012.04.455. |
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consecutive patients with solid lesions who needed to undergo EUS for tissue sampling that had to be performed through the duodenum, such as for deep head/uncinate pancreatic masses, periduodenal lymph nodes, duodenal subepithelial lesions, aortocaval nodes, hilar tumors, right-sided liver lesions, right kidney lesions, right adrenal gland lesions, or periduodenal abdominal masses, were enrolled in the present study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Solid Lesions | Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Solid Lesions | all consecutive patients with solid lesions who needed to undergo EUS for tissue sampling that had to be performed through the duodenum, such as for deep head/uncinate pancreatic masses, periduodenal lymph nodes, duodenal subepithelial lesions, aortocaval nodes, hilar tumors, right-sided liver lesions, right kidney lesions, right adrenal gland lesions, or periduodenal abdominal masses, were enrolled in the present study. Selection criteria All adults (>18 years of age) referred for EUS-FNA of solid lesions adjacent to or located in the wall of the duodenum with no previous tissue diagnosis were considered eligible. In the presence of a cystic component, the solid part of the lesion should have been more than 75% of the total. Patients with uncorrectable coagulopathy as defined by abnormal prothrombin time or partial thromboplastin time that did not normalize after administration of fresh frozen plasma, with altered anatomy of the upper GI tract due to surgery of the esophagus, stomach, and duodenum and those unable to understand and/or read the consent form were excluded from the current study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion | Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients. | Posted | Count of Participants | Participants | Intraoperative |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Solid Lesions | Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Alberto Larghi | Fondazione Policlino Universitario A Gemelli IRCCS | 0630156580 | alberto.larghi@yahoo.it |
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| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Number of Histological Samples Judged Adequate Divided by the Total Number of Patients | percentage of patients in whom a histologically interpretable specimen will be retrieved | 5 days |
| Number of Correct Diagnosis Divided by the Total Number of Patients | rate of correct diagnosis obtained through analysis of the tissue samples acquired with EUS fine needle biopsy | 6 months |
| Paris |
| France |
| AUSL Bologna Bellaria-Maggiore Hospital | Bologna | 40139 | Italy |
| ISMETT UPMC Italy | Palermo | 90100 | Italy |
| Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore | Rome | 00168 | Italy |
| Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology | Kawasaki | Kanagawa | 213-8507 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Complications Divided Per Total Number of Enrolled Patients | rate of complications, divided in procedural complication (perforation, bleeding) occurring during the procedure and late complications (delayed bleeding, infection) occurring during the post-procedural observational period | Posted | Count of Participants | Participants | intraoperative and within 3 days after the procedure |
|
|
|
| Secondary | Number of Histological Samples Judged Adequate Divided by the Total Number of Patients | percentage of patients in whom a histologically interpretable specimen will be retrieved | Posted | Count of Participants | Participants | 5 days |
|
|
|
| Secondary | Number of Correct Diagnosis Divided by the Total Number of Patients | rate of correct diagnosis obtained through analysis of the tissue samples acquired with EUS fine needle biopsy | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 6 |
| 246 |
| 0 |
| 246 |
| acute pancreatitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| duodenal perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| duodenal hematoma | Gastrointestinal disorders | Non-systematic Assessment |
|
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