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

Completed

• Conditions: Digestive Cancer

• Registration Number: NCT03460197
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-09
• Study Start: 2018-04-20
• Primary Completion: 2018-06-20
• Study Completion: 2018-07-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades; 🇲🇽 Mexico City, Cdmx, Mexico