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

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.

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Key information

Conditions

Digestive Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

Mexico City, 06720, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 4 months once the study has begun

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.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Acronym: EUS

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Mar 9, 2018
Registry last updated: Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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