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

March 3, 2021 updated by: Antonio Mendoza-Ladd, Texas Tech University Health Sciences Center, El Paso

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • United States
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center El Paso

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages between 18-80 years old
  2. Sex: male or female
  3. Patients who require EUS and tissue sampling of solid solid lesions (size >1 cm) anywhere in the following locations: lymph nodes, stomach, esophagus, colon, small intestine, pancreas, liver, spleen or kidney.
  4. Patients who are able to give consent

Exclusion Criteria:

  1. Pregnant female
  2. Coagulation disorders (platelets < 50,000/mm3, INR > 2)
  3. Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure.
  4. Cardiorespiratory dysfunction that precludes sedation.
  5. Unable to provide informed consent

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Wet suction
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique
Procedure: Endoscopic ultrasound guided fine needle biopsy
Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
EXPERIMENTAL: Dry suction
This arm will include all the patients that will get and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique
Procedure: Endoscopic ultrasound guided fine needle biopsy
Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
EXPERIMENTAL: Slow pull
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique
Procedure: Endoscopic ultrasound guided fine needle biopsy
Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score
Time Frame: 2 hours

0: inadequate

  1. limited cytological dx
  2. adquate cytological dx
  3. limited histological dx
  4. adequate histological dx with low quality
  5. adequate histological dx with high quality
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Contamination Score of Each Specimen Obtained
Time Frame: 2 hours

This is based on the following scale

  1. Blood present
  2. Blood clots present
2 hours
Number of Participants Stratified Per the Number of Diagnostic Passes Required
Time Frame: 2 hours
This indicates which out of the 3 passes provided enough tissue for diagnosis. If after 3 passes not enough tissue was obtained, the doctor was free to use the technique of his preference outside of the protocol.
2 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University Health Sciences Center, El Paso

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio Mendoza Ladd, MD, Texas Tech University Health Sciences Center, El Paso

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E17118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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