Wet Heparinized Suction for Abdominal Cancer

ConditionsCancer of Pancreas Cancer of Stomach Cancer of Esophagus Cancer of Liver Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 year

Non-pregnant Patients

Patients with the presence of a solid abdominal mass as seen on diagnostic imaging [ie. ultrasound (US), computer tomography (CT) or magnetic resonance imaging (MRI)] scheduled to undergo EUS examination OR Patients who underwent a prior EUS-FNA/FNB for solid pancreatic mass and did not receive a conclusive diagnosis

Patients with platelet count > 50,000

Disqualifiers

Age < 18 years

Pregnant Patients

Patients who cannot consent for themselves

Patients with anticoagulants or anti-platelet agents (excluding aspirin) within the last 7-10 days

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

42 Participants

are divided into 4 treatment groups

Group A: Heparin and microsieveExperimental treatment 2 interventions

Group B: Heparin and no microsieveExperimental treatment 2 interventions

Group C: No heparin and microsieveExperimental treatment 2 interventions

Group D: No heparina nd no microsieveActive comparator 2 interventions

Trial outcomes