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

NCT03460197 | Completed

• 1 other identifier: R-2016-3601-190
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Digestive Cancer

Keywords

Capillary technique; Wet technique; Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Outcome Measures

Primary Outcomes (1)

• The classification of Papanicolaou was used for the terminology in pancreatobiliary cytological evaluation of biopsy samples.

  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.

  4 months once the study has begun

Interventions

Endoscopic Ultrasound-Guided Fine-Needle Aspiration PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Referred to the Endoscopy Department from their corresponding basic health care units within the Mexican Social Security System

You may qualify if:

• Low or moderate suspicious of malignancy lesion in pancreas, liver or metastatic lymph nodes
• Initial diagnosis according to the characterization by endoscopic ultrasound

You may not qualify if:

• Bleeding
• Complications during biopsy procedure
• Needed to use procedures other than those contemplated in the study.
• Patients who not require endoscopic ultrasound evaluation
• Patients who not accept the procedures of the study

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (21)

• 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.

  PMID: 25733127 BACKGROUND

• Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.

  PMID: 28898917 BACKGROUND

• Lakhtakia S. Complications of diagnostic and therapeutic Endoscopic Ultrasound. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):807-823. doi: 10.1016/j.bpg.2016.10.008. Epub 2016 Oct 28.

  PMID: 27931638 BACKGROUND

• Wiersema MJ, Kochman ML, Cramer HM, Tao LC, Wiersema LM. Endosonography-guided real-time fine-needle aspiration biopsy. Gastrointest Endosc. 1994 Nov-Dec;40(6):700-7.

  PMID: 7859968 BACKGROUND

• Hedenstrom P, Demir A, Khodakaram K, Nilsson O, Sadik R. EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions - a prospective, comparative study. Scand J Gastroenterol. 2018 Feb;53(2):231-237. doi: 10.1080/00365521.2017.1421704. Epub 2018 Jan 4.

  PMID: 29301477 BACKGROUND

• Ang TL, Kwek ABE, Wang LM. Diagnostic Endoscopic Ultrasound: Technique, Current Status and Future Directions. Gut Liver. 2018 Sep 15;12(5):483-496. doi: 10.5009/gnl17348.

  PMID: 29291601 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.

  PMID: 25434654 BACKGROUND

• Varadarajulu S, Hasan MK, Bang JY, Hebert-Magee S, Hawes RH. Endoscopic ultrasound-guided tissue acquisition. Dig Endosc. 2014 Jan;26 Suppl 1:62-9. doi: 10.1111/den.12146. Epub 2013 Aug 28.

  PMID: 24033879 BACKGROUND

• Jani BS, Rzouq F, Saligram S, Lim D, Rastogi A, Bonino J, Olyaee M. Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Lesions: A Systematic Review of Technical and Procedural Variables. N Am J Med Sci. 2016 Jan;8(1):1-11. doi: 10.4103/1947-2714.175185.

  PMID: 27011940 BACKGROUND

• Wang J, Wu X, Yin P, Guo Q, Hou W, Li Y, Wang Y, Cheng B. Comparing endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) versus fine needle biopsy (FNB) in the diagnosis of solid lesions: study protocol for a randomized controlled trial. Trials. 2016 Apr 12;17:198. doi: 10.1186/s13063-016-1316-2.

  PMID: 27071386 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.

  PMID: 23433596 BACKGROUND

• Bang JY, Hawes RH, Varadarajulu S. EUS-guided tissue acquisition: things are not always what they seem. Gastrointest Endosc. 2015 May;81(5):1300-1. doi: 10.1016/j.gie.2014.12.044. No abstract available.

  PMID: 25864902 BACKGROUND

• Vilmann P, Seicean A, Saftoiu A. Tips to overcome technical challenges in EUS-guided tissue acquisition. Gastrointest Endosc Clin N Am. 2014 Jan;24(1):109-24. doi: 10.1016/j.giec.2013.08.009.

  PMID: 24215763 BACKGROUND

• Shah JN, Muthusamy VR. Minimizing complications of endoscopic ultrasound and EUS-guided fine needle aspiration. Gastrointest Endosc Clin N Am. 2007 Jan;17(1):129-43, vii-viii. doi: 10.1016/j.giec.2006.10.002.

  PMID: 17397780 BACKGROUND

• Yamao K, Ohashi K, Mizutani S, Furukawa T, Watanabe Y, Nakamura T, Suzuki T, Takeda K. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for the diagnosis of digestive diseases. Endoscopy. 1998 Aug;30 Suppl 1:A176-8. doi: 10.1055/s-2007-1001513. No abstract available.

  PMID: 9765119 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.

  PMID: 19117242 BACKGROUND

• Panic N, Larghi A. Techniques for endoscopic ultrasound-guided fine-needle biopsy. Gastrointest Endosc Clin N Am. 2014 Jan;24(1):83-107. doi: 10.1016/j.giec.2013.08.010.

  PMID: 24215762 BACKGROUND

• Yamao K, Bhatia V, Mizuno N, Sawaki A, Shimizu Y, Irisawa A. Interventional endoscopic ultrasonography. J Gastroenterol Hepatol. 2009 Apr;24(4):509-19. doi: 10.1111/j.1440-1746.2009.05783.x.

  PMID: 19220671 BACKGROUND

• Wee E, Lakhtakia S, Gupta R, Sekaran A, Kalapala R, Monga A, Arjunan S, Reddy DN. Endoscopic ultrasound guided fine-needle aspiration of lymph nodes and solid masses: factors influencing the cellularity and adequacy of the aspirate. J Clin Gastroenterol. 2012 Jul;46(6):487-93. doi: 10.1097/MCG.0b013e31824432cb.

  PMID: 22688144 BACKGROUND

• Hollerbach S, Juergensen C, Hocke M, Freund U, Wellmann A, Burmester E. [EUS-FNA: how to improve biopsy results? An evidence based review]. Z Gastroenterol. 2014 Sep;52(9):1081-92. doi: 10.1055/s-0034-1385133. Epub 2014 Sep 8. German.

  PMID: 25198088 BACKGROUND

• Paquin SC, Sahai AV. Techniques for EUS-guided FNA cytology. Gastrointest Endosc Clin N Am. 2014 Jan;24(1):71-81. doi: 10.1016/j.giec.2013.08.007.

  PMID: 24215761 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Dulce M. Rascon, M.D

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

• Alejandro Membrillo, Endoscopist

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Luis F. Palacio, Endoscopist

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Luz M. Gomez, Pathologist

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Yelitzia A. Valverde, Pathologist

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Clinical Researcher.

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: March 9, 2018
• Study Start: April 20, 2018
• Primary Completion: June 20, 2018
• Study Completion: July 20, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

ME (1)