Comparing the Franseen and Fork-top Needles for EUS-guided Fine-needle Biopsy of Solid Mass Lesions.

NCT03561038 | Withdrawn

• 1 other identifier: 217910
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This will be a randomized controlled trial of all the patients referred to University of Arkansas Medical for Medical Sciences (UAMS) for endoscopic ultrasound (EUS) guided biopsy of solid mass lesions. EUS guided tissue acquisition will be performed in all these patients using both needle types (22-gauge Franseen Fine Needle Biopsy (FNB) (Acquire, Boston Scientific Corporation, Natick, Mass) and 22-gauge Fork-tip FNB needle (SharkCore, Medtronic)) with randomization of the order in which the needle will be used.

Conditions

Solid Mass Lesions in GI Tract

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield

  comparing rates of diagnostic yield between the 2 cohorts.

  Up to 2 years

Secondary Outcomes (1)

• Histology

  up to 2 years

Study Arms (2)

Franseen Needle

ACTIVE COMPARATOR

2 strokes within the mass with Franseen Needle, and then 2 strokes with the Fork-tip Needle

Device: Franseen Needle

Fork-tip Needle

ACTIVE COMPARATOR

2 strokes within the mass with Fork-Tip needle, and then 2 strokes with the Franseen Needle

Device: Fork-tip Needle

Interventions

Franseen Needle DEVICE

Comparing 2 needles designed for tissue acquisition

Franseen Needle

Fork-tip Needle DEVICE

Comparing 2 needles designed for tissue acquisition

Fork-tip Needle

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects from any ethnic background
• Successfully completes the screening process
• Has signed written informed consent by patient or surrogate
• Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of study questionnaires.
• Patients must have evidence of a lesion seen on endoscopic ultrasound that is accessible
• Lack of severe or terminal co-morbidity, as judged by the generalists or specialists caring for the patient.

You may not qualify if:

• History of allergic reaction of hypersensitivity to the medications / anesthesia.
• Female participants of childbearing age who are pregnant
• Female participants who are breastfeeding.
• Participant has history of significant cardiovascular or pulmonary disease (e.g., myocardial infarct, unstable angina, congestive heart failure, arrhythmia, pulmonary edema or COPD), or other significant cerebrovascular disease (stroke)
• Patients who are uncooperative, unable to give written informed consent, who cannot return for follow-up, or refuse informed consent
• Persistent shock or hypertension (e.g., systolic blood pressure less than or equal to 99 mm mercury) that is unresponsive to less than or equal to 6 units of packed red blood cell (RBC) transfusions or requires continuous intravenous infusions of vasoactive drugs for blood pressure elevation.
• Severe coagulopathy unresponsive to blood transfusions (e.g., international normalized ratio \>2.0, platelet count \<20,000. activated partial thromboplastin time greater than 2.0 x normal, or bleeding time \> 10 minutes)
• Contraindication to urgent endoscopy or follow-up procedures or inaccessible due to altered anatomy, moderate / tense ascites.
• Participant has uncontrolled diabetes / uncontrolled hypertension / severe immunodeficiency.

Sponsors & Collaborators

• University of Arkansas: lead

Study Officials

• Sumant Inamdar, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 19, 2018
• Study Start: April 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 3, 2024

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share