Clinical Trials Directory

Trials / Terminated

TerminatedNCT03264092

Comparison of Three Tissue Acquiring Techniques During EUS Guided Biopsies of Solid Tumors.

Comparison of Three Different Tissue Acquisition Techniques During Endoscopic Ultrasound-guide Fine Needle Biopsies of Solid Tumors: A Randomized Single Blind Clinical Trial.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Texas Tech University Health Sciences Center, El Paso · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.

Detailed description

Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has been used since 1990's for the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal mediastinal lesions and intra-abdominal lymphadenopathy. Studies have shown a variable range of specimen adequacy when performing pancreatic biopsies with the standard fine needle aspiration (FNA) needles with this modality. There are several factors that affect the overall diagnostic yield of this procedure, such as endosonographer experience, presence of cytopathologist during the procedure, the needle diameter and the number of passes. In this study we will compare the yield of recently available fine biopsy needles (FNB) using three different techniques to obtain samples from solid lesions. The three techniques to be compared in this study are: stylet slow pull (SP) vs dry suction (DS) vs wet suction (WS). wall cells. In the "suction technique" the stylet of the needle can be left in place or removed before puncturing the lesion. Once the needle is inside the target, negative pressure is applied through a 10 or 20 cc syringe connected to the needle. The wet suction technique consists of flushing of the needle with 5 ml of saline solution to replace the column of air within the lumen of needle with saline solution before needle aspiration. Once the needle is flushed, negative pressure is applied with a 10 or 20 cc syringe connected to the needle. In the slow pull technique, the stylet is left in place in the needle and is slightly retracted prior to puncturing the lesion. Once the needle is inside the target, the stylet is pushed completely into the needle to remove any contaminant cells and several back and forth movements are done while slowly withdrawing the stylet.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndoscopic ultrasound guided fine needle biopsyUsing the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance

Timeline

Start date
2017-09-11
Primary completion
2020-10-01
Completion
2020-10-01
First posted
2017-08-28
Last updated
2021-04-01
Results posted
2021-04-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03264092. Inclusion in this directory is not an endorsement.