Wet Heparinized Suction for Abdominal Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05041335
Status
Not Yet Recruiting

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Conditions

  • Cancer
  • Cancer of Esophagus
  • Cancer of Liver
  • Cancer of Pancreas
  • Cancer of Stomach

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • wet heparinzed suction — OTHER
    Needle flushed with 5000 Units in 10mL of heparin
  • Microsieve — OTHER
    A microsieve used for tissue preparation
  • No heparin flush — OTHER
    The needle not prepped
  • No microsieve — OTHER
    The tissue is placed into formalin

Study Details

The purpose of this research is to compare the amount and quality of tissue obtained by EUS-FNB when the device is flushed with an anticoagulant or "blood thinner" vs. saline a salt water solution as well as the use of a microsieve in order for the doctor to look at the tissue to check the acceptability of the specimens before sending for analysis. You will be randomly assigned (like a flip of a coin) to have either the blood thinner or the salt water solution placed within the needle being used to sample your abdominal tumor and to have either a sieve used or not. You will be one of 42 participants enrolled in this data collection study which includes 1 sites in the United States.

Key Dates

Start date
Mar 15, 2026
Status verified
Apr 2025
Primary completion
Jan 12, 2027
Completion
Jan 12, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Heparin and microsieve
    The needle will be prepped with 500 U heparin USP per 10 mL to coat the inside of the needle. The provider will expel the tissue onto the microsieve
  • Experimental: Heparin and no microsieve
    The needle will be prepped with 500 U heparin USP per 10 mL to coat the inside of the needle. The provider will expel the tissue into formalin
  • Experimental: No heparin and microsieve
    The needle not be prepped. The provider will expel the tissue onto the microsieve
  • Active Comparator: No heparina nd no microsieve
    The needle not be prepped. The provider will expel the tissue into formalin

Primary Outcome Measure

Aggregate specimen length (ASL) [ Time Frame: immediately after the intervention/procedure/surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Shaffer Mok, MD
813-745-4673

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