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Preliminary analysis of the results showed no statistically significant difference
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The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.
Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has been used since 1990's for the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal mediastinal lesions and intra-abdominal lymphadenopathy. Studies have shown a variable range of specimen adequacy when performing pancreatic biopsies with the standard fine needle aspiration (FNA) needles with this modality. There are several factors that affect the overall diagnostic yield of this procedure, such as endosonographer experience, presence of cytopathologist during the procedure, the needle diameter and the number of passes. In this study we will compare the yield of recently available fine biopsy needles (FNB) using three different techniques to obtain samples from solid lesions. The three techniques to be compared in this study are: stylet slow pull (SP) vs dry suction (DS) vs wet suction (WS).
wall cells.
In the "suction technique" the stylet of the needle can be left in place or removed before puncturing the lesion. Once the needle is inside the target, negative pressure is applied through a 10 or 20 cc syringe connected to the needle.
The wet suction technique consists of flushing of the needle with 5 ml of saline solution to replace the column of air within the lumen of needle with saline solution before needle aspiration. Once the needle is flushed, negative pressure is applied with a 10 or 20 cc syringe connected to the needle.
In the slow pull technique, the stylet is left in place in the needle and is slightly retracted prior to puncturing the lesion. Once the needle is inside the target, the stylet is pushed completely into the needle to remove any contaminant cells and several back and forth movements are done while slowly withdrawing the stylet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wet suction | Experimental | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique |
|
| Dry suction | Experimental | This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique |
|
| Slow pull | Experimental | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound guided fine needle biopsy | Procedure | Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance |
| Measure | Description | Time Frame |
|---|---|---|
| Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score | 0: inadequate
| 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Contamination Score of Each Specimen Obtained | This is based on the following scale
| 2 hours |
| Number of Participants Stratified Per the Number of Diagnostic Passes Required |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Mendoza Ladd, MD | Texas Tech University Health Sciences Center, El Paso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech university Health Sciences Center El Paso | El Paso | Texas | 79905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16322944 | Background | Yamao K, Sawaki A, Mizuno N, Shimizu Y, Yatabe Y, Koshikawa T. Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB): past, present, and future. J Gastroenterol. 2005 Nov;40(11):1013-23. doi: 10.1007/s00535-005-1717-6. | |
| 19117242 | Background | Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392. |
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The study was terminated early given the difficulty we experienced enrolling patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wet Suction | This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17 Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance |
| FG001 | Dry Suction | This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20 Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance |
| FG002 | Slow Pull | This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=17 Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wet Suction | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance |
| 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 | Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score | 0: inadequate
| Posted | Mean | Standard Deviation | units on a scale | 2 hours |
|
2 hours
Adverse events evaluated in this study were: bleeding, bowel perforation and hemodynamic instability. The definitions of these adverse events are similar to the ones established by clinicaltrials.gov
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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 | Wet Suction | This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17 subjects |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Gastrointestinal disorders | Non-systematic Assessment | Bleeding from the puncture site. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Antonio Mendoza Ladd | Texas Tech University Health Sciences Center | 9152154678 | antonio.mendoza-ladd@ttuhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2020 | Oct 15, 2020 | Prot_SAP_000.pdf |
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This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol.
| 2 hours |
| 34859313 | Derived | Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2. |
| BG001 |
| Dry Suction |
This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance |
| BG002 | Slow Pull | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique Endoscopic ultrasound guided fine needle biopsy: Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Slow Pull |
This arm describes the mean cellularity score obtained with the slow pull technique. |
|
|
|
| Secondary | Blood Contamination Score of Each Specimen Obtained | This is based on the following scale
| Posted | Number | participants | 2 hours |
|
|
|
|
| Secondary | Number of Participants Stratified Per the Number of Diagnostic Passes Required | This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol. | Diagnostic passes 4 and above were considered outside of protocol | Posted | Number | participants | 2 hours |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Dry Suction | This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20 subjects | 0 | 20 | 0 | 20 | 3 | 20 |
| EG002 | Slow Pull | This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=18 subjects \ | 0 | 18 | 0 | 18 | 0 | 18 |
|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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| Diagnostic pass 3 |
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| Diagnostic pass 4 |
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| Diagnostic pass 5 |
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| Diagnostic pass 6 |
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