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

Sponsor
Instituto Mexicano del Seguro Social (Other)
Overall Status
Completed
CT.gov ID
NCT03460197
Collaborator
(none)
30
Enrollment
1
Location
3
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Apr 20, 2018
Actual Primary Completion Date :
Jun 20, 2018
Actual Study Completion Date :
Jul 20, 2018

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades Mexico City Cdmx Mexico 06720

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Mar 9, 2018
Last Update Posted:
Feb 28, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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, MD Clinical Researcher., Instituto Mexicano del Seguro Social
Capillary technique
Wet technique
Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Study Results

No Results Posted as of Feb 28, 2019