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Patients will be submitted to both techniques of tissue acquisition in the same procedure of endoscopic ultrasound. Capillarity technique, requires not remove the stiletto from the needle until the punctures are done for the biopsy sampling. Wet suction technique, requires saline solution to replace the air column. Samplings will be placed in two different jars, where Jar 1 corresponds to Capillarity Technique sampling and Jar 2 to Wet Technique. Once the sampling preparation is concluded will be send to the Pathology Department to be subsequently blindly analyzed by two independent pathologists, that means they would not be aware of the tissue acquisition method used in each of the microscopic slides to analyze.

Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Dulce M. Rascon, M.D

Alejandro Membrillo, Endoscopist

Luis F. Palacio, Endoscopist

Luz M. Gomez, Pathologist

Yelitzia A. Valverde, Pathologist

There are various techniques to obtain tissue samples by using fine needle guided by endoscopic ultrasound (EUS). These techniques attempt to obtain the most adequate material with the best quantity and quality for analysis. Currently studies that compare the results concerning capillary technique versus wet technique are not available. In this sense, the authors consider necessary to explore both techniques documenting the results that can define which could be the best method so that it can routinely be used in cases of digestive neoplasia.

The aim of the study will be compare both techniques guided by endoscopic ultrasound (Capillarity versus Wet) and identify which obtains the best sample quality for histopathology analysis as tissue acquisition method in patients diagnosed with tumors of pancreas, biliary tract, liver or lymph nodes.

The researchers are planning a prospective, pilot study in 30 subjects. All patients will be submitted to both techniques of tissue acquisition (capillarity versus wet) in the same procedure of endoscopic ultrasound. Obtained samples for histopathology analysis will be submitted to a blind examination by two different pathologists.

Biopsies of suspicious digestive tumors obtained by endoscopic -ultrasound. Cellularity and sample quality will be documented.

Comparison Between Two Tissue Acquisition Techniques by Endoscopic Ultrasound. (EUS)

Capillarity Versus Wet Technique. Comparison Between Two Methods of Tissue Acquisition Guided by Endoscopic Ultrasound.

This is a pilot study. It means a few patients will be included. We are not subjecting the participants to a higher risk than the endoscopic ultrasound itself and the procedures performed here are usual. The authors will only document the experience.

I.- Non-diagnostic: Specimen does not provide information about whether the lesion is cystic or solid.

II.- Negative (for malignancy): Specimen has adequate cellularity and / or extracellular material that defines a lesion that is identified by image.

III.- Atypical: There are cells with architectural, nuclear or cytoplasmic that are not consistent with reactive changes. However, these findings are not conclusive to diagnose malignancy or suspected of malignancy.

IV.- Neoplastic: benign and others. Neoplasic benign: Sample has elements of benign neoplasm. Neoplastic others: May be is a premalignant lesion like low-level dysplasia, intermediate or high grade dysplasia or a low grade neoplasm with malignant behavior.

V.- Suspected of malignancy: Cytological characteristics support the Diagnosis of malignancy but quantitatively or qualitatively is not enough to confirm it.

VI.- Positive / malignant: Cytological changes are unequivocal of malignancy.

Instituto Mexicano del Seguro Social

MD Clinical Researcher.

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Pancreatic Cancer

Stomach Cancer

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.

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.

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.

modified wet-suction technique

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.

Capillary "slow pull" technique

Alexander Jahng, M.D

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:

1. The stylet will be removed at the onset of procedure. It will not be used unless it is necessary to de-clog the needle. Each de-clogging, if necessary, will be noted.
2. 10 mL suction syringe filled with saline will be used first to prime the needle until there is about 5 mL of saline left within the syringe
3. Then the plunger will be withdrawn against the locked three-way stopcock to establish vacuum. After this initial step, syringe with saline will not be removed for the entirety of the procedure unless technical issues arise, e.g. de-clogging.
4. Once the needle is introduced into the lesion of interest, the suction will be re-established by opening the three-way stopcock.
5. 10-20 to-and-fro needle motions will be done, emphasizing the edges of the lesion with fanning.
6. At the termination of each pass, the three-way stopcock will be closed prior to withdrawal of the needle from the lesion, to prevent suction of the specimen into the syringe itself.
7. Prior to steps to collect the specimen, the vacuum will be released, and after which the three-way stopcock will be turned to the open position.
8. Then the syringe plunger will then be pushed to collect the first drop of the specimen onto the glass slide for smear (thus making two glass smears for each pass, which will then be preserved into alcohol), and then the rest will be expunged onto the formalin for cell block.
9. Then the vacuum will be re-established as noted in step 3, ready for further needle passes.
10. For the first three passes, collection for both smear and the cell block will be done. For the last pass, all specimens will be collected on to the same cell block. Thus 6 total slides (which will be numbered or lettered consecutively for identification), and 1 formalin jar for cell block will be made for each patient/lesion.
11. Again, unless technical issues arise, the syringe will not be removed once initial priming is done and vacuum is established. Any technical issues will be noted within the procedure report.

For the capillary "slow pull" technique:

1. With the stylet slightly pulled back, the needle will be introduced into the lesion of interest, at which time the stylet will be pushed in to expunge any contaminating material.
2. The stylet will be slowly withdrawn by an assistant until completely removed.
3. 10-20 to-and-fro needle motions will be done, emphasizing the edges of the lesion with fanning.
4. After removal of the needle from the lesion, the stylet will be re-inserted. The first drop of will be collected for tissue smear, while the rest will be expunged first by stylet, saline, then air into formalin jar for cell block.
5. Stylet will then be re-introduced, ready for further passes.
6. For the first three passes, collection for both smear and the cell block will be done. For the last pass, all specimens will be collected on to the same cell block. Thus 6 total slides (which will be numbered or lettered consecutively for identification), and 1 formalin jar for cell block will be made for each patient/lesion.

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

Modified Wet Suction Versus Capillary Techniques for EUS Guided Fine Needle Aspiration and Biopsy of Solid Lesions

Each tissue acquisition histology with be compared to final histology or diagnosis and from this we can calculate a percentage of accurate tissue acquisition.

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison Between Two Tissue Acquisition Techniques by Endoscopic Ultrasound. (EUS)	NCT03460197	Digestive Cance...	Endoscopic Ultr...	18 Years - 80 Years	Instituto Mexicano del Seguro Social
Modified Wet Suction Versus Capillary Techniques for EUS Guided Fine Needle Aspiration and Biopsy of Solid Lesions	NCT02919553	Pancreatic Canc... Stomach Neoplas...	modified wet-su... Capillary "slow...	18 Years -	Loma Linda University

Spots Global Cancer Trial Database for capillary technique