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

February 26, 2019 updated by: Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Cdmx
      • Mexico City, Cdmx, Mexico, 06720
        • Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months once the study has begun

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

June 20, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-2016-3601-190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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