Abdominal Neoplasms
Conditions
Keywords
EUS-guided biopsy, EUS-FNB
Brief summary
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.
Detailed description
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.
Interventions
DEVICEExpect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)
EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Intraoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Complications Divided Per Total Number of Enrolled Patients | intraoperative and within 3 days after the procedure | 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 |
| Number of Histological Samples Judged Adequate Divided by the Total Number of Patients | 5 days | percentage of patients in whom a histologically interpretable specimen will be retrieved |
| Number of Correct Diagnosis Divided by the Total Number of Patients | 6 months | rate of correct diagnosis obtained through analysis of the tissue samples acquired with EUS fine needle biopsy |
Countries
France, Italy, Japan, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 246 |
| Total | 246 |
Baseline characteristics
| Characteristic | Patients With Solid Lesions | — |
|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 12.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 39 participants | — |
| Region of Enrollment Italy | 152 participants | — |
| Region of Enrollment Japan | 25 participants | — |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 102 Participants | — |
| Sex: Female, Male Male | 144 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 246 |
| serious Total, serious adverse events | 6 / 246 |
Outcome results
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.
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Solid Lesions | 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 | 228 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
Time frame: intraoperative and within 3 days after the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Solid Lesions | Number of Complications Divided Per Total Number of Enrolled Patients | 6 Participants |
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Solid Lesions | Number of Correct Diagnosis Divided by the Total Number of Patients | 181 Participants |
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
Time frame: 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Solid Lesions | Number of Histological Samples Judged Adequate Divided by the Total Number of Patients | 189 Participants |