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Modified Wet Suction Versus Capillary Techniques for EUS Guided Fine Needle Aspiration and Biopsy of Solid Lesions

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ClinicalTrials.gov Identifier: NCT02919553
Recruitment Status : Withdrawn (decided not to proceed with study at this time)
First Posted : September 29, 2016
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Alexander Jahng, MD, Loma Linda University

Brief Summary:
The purpose of the study is to compare two particular techniques of tissue (capillary vs wet-suction techniques) sampling during endoscopic ultrasound guided fine needle aspiration/biopsy (EUS-FNA/FNB) of a solid lesion to determine the diagnostic yield and procedure logistics (e.g. procedure time).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Stomach Neoplasms Procedure: modified wet-suction technique Procedure: Capillary "slow pull" technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Modified Wet Suction Versus Capillary Techniques for EUS Guided Fine Needle Aspiration and Biopsy of Solid Lesions
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: modified wet-suction technique
Patients in this arm will undergo the modified wet-suction technique. Details in the study description section. After sufficient sampling of the lesion, the needle will be removed and the specimen will be collected.
Procedure: modified wet-suction technique
Normal saline will be present in this needle, and once in the lesion of interest the suction will be re-established and the needle will be moved in a to-and-fro motion to collect the sample of interest. Then the sample will be collected.

Active Comparator: Capillary "slow pull" technique
Patients in this arm will undergo the Capillary "slow pull" technique which will include moving the needle to-and-fro into the lesion. Subsequently the needle will be removed and the specimen will be collected.
Procedure: Capillary "slow pull" technique
The needle will be introduced into the lesion of interest and using the to-and-fro motion, collect the sample. The needle will then be withdrawn and the sample will then be collected.




Primary Outcome Measures :
  1. Rate of core tissue acquisition adequate for histologic analysis. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Diagnostic yield will measure the percentage of tissue acquisition cases that matched up with the final diagnosis. [ Time Frame: 4 weeks ]
    Each tissue acquisition histology with be compared to final histology or diagnosis and from this we can calculate a percentage of accurate tissue acquisition.

  2. Procedure time [ Time Frame: 4 weeks ]
  3. Tissue smear and cell block cellularity will be graded along this scale: Cellularity, graded 0 = no cells, 1 = sparsely cellular, 2 = moderately cellular, and 3 = highly cellular. [ Time Frame: 4 weeks ]
    Each case will tallied into each graded category as noted above: no cells, sparsely cellular, moderately cellular, highly cellular. From there a percentage from the total number can be ascertained, median and mode can be calculated. The different percentage between tissue smear and cell block can be evaluated.

  4. Tissue smear and cell block will be assessed of blood contamination with this scale: graded 0 = free of contamination, 1 = contaminated, 2 = highly contaminated, with or without blood clots. [ Time Frame: 4 weeks ]
    Each case will tallied into each graded category as noted above: 0 = free of contamination, 1 = contaminated, 2 = highly contaminated, with or without blood clots. From there a percentage from the total number can be ascertained, median and mode can be calculated. The different percentage between tissue smear and cell block can be evaluated.

  5. Tissue smear and cell block will be assessed of insertion tissue contamination with this scale: graded 0 = free of contamination, 1 = contaminated, 2 = highly contaminated. [ Time Frame: 4 weeks ]
    Each case will tallied into each graded category as noted above: 0 = free of contamination, 1 = contaminated, 2 = highly contaminated. From there a percentage from the total number can be ascertained, median and mode can be calculated. The different percentage between tissue smear and cell block can be evaluated.

  6. Tissue smear and cell block will be assessed of diagnosis characteristic with this scale: 0 = not adequate, 1 = suspicious for particular etiology, 2 = diagnostic for etiology, e.g. cancer. [ Time Frame: 4 weeks ]
    Each case will tallied into each graded category as noted above: 0 = not adequate, 1 = suspicious for particular etiology, 2 = diagnostic for etiology, e.g. cancer. From there a percentage from the total number can be ascertained, median and mode can be calculated. The different percentage between tissue smear and cell block can be evaluated.

  7. Cell block will be assessed of presence of any core tissue with intact architecture with this scale: graded 0 = none, 1 = present but marginal adequacy, 2 = present and adequate. Dimensions of the largest core will be noted if possible. [ Time Frame: 4 weeks ]
    Each case will tallied into each graded category as noted above: 0 = none, 1 = present but marginal adequacy, 2 = present and adequate. From there a percentage from the total number can be ascertained, median and mode can be calculated.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • All adult patients (greater than 18 years of age) who are referred for EUS guided sampling of solid lesions.

Exclusion Criteria:

  • Any patients with contraindication to EUS- fine-needle aspiration/fine-needle biopsy (FNA/B), including those on anti-platelet or on anti-coagulation therapy, or with congenital disorders.
  • Patients with cystic lesions or submucosal lesions will also be excluded.

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): NCT02919553


Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Alexander Jahng, M.D Loma Linda Univ Medical gastroenterology
Publications:

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Responsible Party: Alexander Jahng, MD, Gastroenterology attending, Loma Linda University
ClinicalTrials.gov Identifier: NCT02919553    
Other Study ID Numbers: 5160355
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
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
Keywords provided by Alexander Jahng, MD, Loma Linda University:
endoscopic ultrasound
wet-suction technique
capillary technique
fine needle aspiration
fine needle biopsy
Additional relevant MeSH terms:
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Stomach Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases