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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460197
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social

Study Description
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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.

Condition or disease Intervention/treatment
Digestive Cancer Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Capillarity Versus Wet Technique. Comparison Between Two Methods of Tissue Acquisition Guided by Endoscopic Ultrasound.
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Intervention Details:
  • Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples Without DNA
Biopsies of suspicious digestive tumors obtained by endoscopic -ultrasound. Cellularity and sample quality will be documented.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460197


Locations
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Mexico
Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
Mexico City, Cdmx, Mexico, 06720
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Study Director: Dulce M. Rascon, M.D Instituto Mexicano del Seguro Social
Principal Investigator: Alejandro Membrillo, Endoscopist Instituto Mexicano del Seguro Social
Study Chair: 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
More Information
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Publications:

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Responsible Party: Dulce Maria Rascon Martinez, MD Clinical Researcher., Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT03460197    
Other Study ID Numbers: R-2016-3601-190
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social:
Capillary technique
Wet technique
Endoscopic Ultrasound-Guided Fine-Needle Aspiration