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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Solid Mass Lesions in GI Tract
• Intervention / Treatment: Device: Franseen Needle; Device: Fork-tip Needle

Detailed Description

All procedures will be performed by the advance endoscopists Dr Sumant Inamdar (SI) and Dr Benjamin Tharian (BT) using a linear array echoendoscope (Olympus UCT180, Olympus America Corp, Center Valley, Pa) with patients in the left lateral decubitus position after administration of anesthesia (propofol or general anesthesia). During EUS, the mass will first be punctured using either needle based on the randomization assignment. Tissue acquisition will be performed using the fanning maneuver (4 strokes at 4 different locations within the mass). After performing 2 dedicated passes for cell block for histological analysis using the randomized needle, 2 additional passes will be made for cell block with the alternate needle. Sample obtained from each pass is placed into a separate container to be analysed separately. The occurrence of immediate adverse events will be noted at the time of procedure, and late adverse events will be documented by follow-up telephone calls at 1 week post-procedure

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Franseen Needle; 2 strokes within the mass with Franseen Needle, and then 2 strokes with the Fork-tip Needle	Device: Franseen Needle; Comparing 2 needles designed for tissue acquisition
Active Comparator: Fork-tip Needle; 2 strokes within the mass with Fork-Tip needle, and then 2 strokes with the Franseen Needle	Device: Fork-tip Needle; Comparing 2 needles designed for tissue acquisition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield	comparing rates of diagnostic yield between the 2 cohorts.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histology	Histology will be evaluated	up to 2 years

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Sumant Inamdar, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 217910

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No