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

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ClinicalTrials.gov Identifier: NCT03264092
Recruitment Status : Terminated (Preliminary analysis of the results showed no statistically significant difference)
First Posted : August 28, 2017
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Antonio Mendoza-Ladd, Texas Tech University Health Sciences Center, El Paso

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

Condition or disease Intervention/treatment Phase
Solid Tumor Procedure: Endoscopic ultrasound guided fine needle biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Three Different Tissue Acquisition Techniques During Endoscopic Ultrasound-guide Fine Needle Biopsies of Solid Tumors: A Randomized Single Blind Clinical Trial.
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264092


Locations
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United States, Texas
Texas Tech university Health Sciences Center El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
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Principal Investigator: Antonio Mendoza Ladd, MD Texas Tech University Health Sciences Center, El Paso
  Study Documents (Full-Text)

Documents provided by Antonio Mendoza-Ladd, Texas Tech University Health Sciences Center, El Paso:
Publications:
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Responsible Party: Antonio Mendoza-Ladd, Assistant Professor of Medicine, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT03264092    
Other Study ID Numbers: E17118
First Posted: August 28, 2017    Key Record Dates
Results First Posted: April 1, 2021
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms