Clinical trial NCT03460197: Comparison Between Two Tissue Acquisition Techniques by Endoscopic Ultrasound. (EUS)
Official title: Capillarity Versus Wet Technique. Comparison Between Two Methods of Tissue Acquisition Guided by Endoscopic Ultrasound.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive Cancer
Keywords: Capillary technique
Wet technique
Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2018-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: The classification of Papanicolaou was used for the terminology in pancreatobiliary cytological evaluation of biopsy samples.
timeFrame: 4 months once the study has begun
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
state: Cdmx
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Dulce M. Rascon, M.D
role: STUDY_DIRECTOR
affiliation: Instituto Mexicano del Seguro Social
name: Alejandro Membrillo, Endoscopist
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Mexicano del Seguro Social
name: Luis F. Palacio, Endoscopist
role: STUDY_CHAIR
affiliation: Instituto Mexicano del Seguro Social
name: Luz M. Gomez, Pathologist
role: STUDY_CHAIR
affiliation: Instituto Mexicano del Seguro Social
name: Yelitzia A. Valverde, Pathologist
role: STUDY_CHAIR
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