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decided not to proceed with study at this time
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The purpose of the study is to compare two particular techniques of tissue (capillary vs wet-suction techniques) sampling during endoscopic ultrasound guided fine needle aspiration/biopsy (EUS-FNA/FNB) of a solid lesion to determine the diagnostic yield and procedure logistics (e.g. procedure time).
All adult patients who are undergoing EUS for solid lesions at Loma Linda University Health gastroenterology lab. These patients will be recruited at the time preceding their endoscopy in the Gastroenterology lab. They will be explained the goals, randomization, and interventions of the study. The collected patient information, as well as the steps to safeguard the information, will be explained.
Patients will be randomly assigned to capillary or wet-suction techniques arms according to computerized randomization program that has already been generated.
All patients will undergo routine EUS under possible moderate sedation or general anesthesia, with FNA/FNB. Cook Pro-core 22 gauge needle will be used for all the procedures. For each lesion undergoing FNA/FNB procedure, a total of 4 passes will be made using the selected technique.
The research aspect differentiates the method of tissue acquisition: modified wet-suction technique versus the "slow pull" capillary technique.
For the modified wet-suction technique:
For the capillary "slow pull" technique:
Specimen handling:
Tissue smears will undergo for Papanicolaou staining, and the tissues preserved in 10% formalin solution will be processed for cell block.
The subjects will follow up with the Gastroenterology Clinic and/or their referring doctor. Patient may be called or receive a letter regarding their pathology results and for further follow-up as needed, per routine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified wet-suction technique | Experimental | Patients in this arm will undergo the modified wet-suction technique. Details in the study description section. After sufficient sampling of the lesion, the needle will be removed and the specimen will be collected. |
|
| Capillary "slow pull" technique | Active Comparator | Patients in this arm will undergo the Capillary "slow pull" technique which will include moving the needle to-and-fro into the lesion. Subsequently the needle will be removed and the specimen will be collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified wet-suction technique | Procedure | Normal saline will be present in this needle, and once in the lesion of interest the suction will be re-established and the needle will be moved in a to-and-fro motion to collect the sample of interest. Then the sample will be collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of core tissue acquisition adequate for histologic analysis. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield will measure the percentage of tissue acquisition cases that matched up with the final diagnosis. | Each tissue acquisition histology with be compared to final histology or diagnosis and from this we can calculate a percentage of accurate tissue acquisition. | 4 weeks |
| Procedure time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Jahng, M.D | Loma Linda Univ Medical gastroenterology | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25434654 | Background | Wani S, Muthusamy VR, Komanduri S. EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc. 2014 Dec;80(6):939-59.e7. doi: 10.1016/j.gie.2014.07.066. No abstract available. | |
| 24325591 | Background | Kim GH, Cho YK, Kim EY, Kim HK, Cho JW, Lee TH, Moon JS; Korean EUS Study Group. Comparison of 22-gauge aspiration needle with 22-gauge biopsy needle in endoscopic ultrasonography-guided subepithelial tumor sampling. Scand J Gastroenterol. 2014 Mar;49(3):347-54. doi: 10.3109/00365521.2013.867361. Epub 2013 Dec 11. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
| Capillary "slow pull" technique | Procedure | The needle will be introduced into the lesion of interest and using the to-and-fro motion, collect the sample. The needle will then be withdrawn and the sample will then be collected. |
|
| 4 weeks |
| Tissue smear and cell block cellularity will be graded along this scale: Cellularity, graded 0 = no cells, 1 = sparsely cellular, 2 = moderately cellular, and 3 = highly cellular. | Each case will tallied into each graded category as noted above: no cells, sparsely cellular, moderately cellular, highly cellular. From there a percentage from the total number can be ascertained, median and mode can be calculated. The different percentage between tissue smear and cell block can be evaluated. | 4 weeks |
| Tissue smear and cell block will be assessed of blood contamination with this scale: graded 0 = free of contamination, 1 = contaminated, 2 = highly contaminated, with or without blood clots. | Each case will tallied into each graded category as noted above: 0 = free of contamination, 1 = contaminated, 2 = highly contaminated, with or without blood clots. From there a percentage from the total number can be ascertained, median and mode can be calculated. The different percentage between tissue smear and cell block can be evaluated. | 4 weeks |
| Tissue smear and cell block will be assessed of insertion tissue contamination with this scale: graded 0 = free of contamination, 1 = contaminated, 2 = highly contaminated. | Each case will tallied into each graded category as noted above: 0 = free of contamination, 1 = contaminated, 2 = highly contaminated. From there a percentage from the total number can be ascertained, median and mode can be calculated. The different percentage between tissue smear and cell block can be evaluated. | 4 weeks |
| Tissue smear and cell block will be assessed of diagnosis characteristic with this scale: 0 = not adequate, 1 = suspicious for particular etiology, 2 = diagnostic for etiology, e.g. cancer. | Each case will tallied into each graded category as noted above: 0 = not adequate, 1 = suspicious for particular etiology, 2 = diagnostic for etiology, e.g. cancer. From there a percentage from the total number can be ascertained, median and mode can be calculated. The different percentage between tissue smear and cell block can be evaluated. | 4 weeks |
| Cell block will be assessed of presence of any core tissue with intact architecture with this scale: graded 0 = none, 1 = present but marginal adequacy, 2 = present and adequate. Dimensions of the largest core will be noted if possible. | Each case will tallied into each graded category as noted above: 0 = none, 1 = present but marginal adequacy, 2 = present and adequate. From there a percentage from the total number can be ascertained, median and mode can be calculated. | 4 weeks |
| 23504350 | Background | Krishnan K, Dalal S, Nayar R, Keswani RN, Keefer L, Komanduri S. Rapid on-site evaluation of endoscopic ultrasound core biopsy specimens has excellent specificity and positive predictive value for gastrointestinal lesions. Dig Dis Sci. 2013 Jul;58(7):2007-12. doi: 10.1007/s10620-013-2613-1. Epub 2013 Mar 17. |
| 24944988 | Background | Keswani RN, Krishnan K, Wani S, Keefer L, Komanduri S. Addition of Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration and On-Site Cytology to EUS-Guided Fine Needle Biopsy Increases Procedure Time but Not Diagnostic Accuracy. Clin Endosc. 2014 May;47(3):242-7. doi: 10.5946/ce.2014.47.3.242. Epub 2014 May 31. |
| 23433596 | Background | Iwashita T, Nakai Y, Samarasena JB, Park DH, Zhang Z, Gu M, Lee JG, Chang KJ. High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions. Gastrointest Endosc. 2013 Jun;77(6):909-15. doi: 10.1016/j.gie.2013.01.001. Epub 2013 Feb 20. |
| 25733127 | Background | Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |