EUS-FNB vs. Single-incision Needle-knife (SINK) Biopsy for Gastrointestinal SELs

Summary

Sub epithelial lesions (SELs) of the gastrointestinal (GI) tract are commonly identified during routine endoscopy. Most of these lesions are benign. However because there is the potential for malignant transformation it is important to correctly identify the lesion in order to determine if any further therapy and/or surveillance is necessary for the patient, particularly for gastrointestinal stromal tumors (GISTs).

Obtaining a definitive diagnosis for SELs is often difficult since biopsies of the normal overlying surface mucosal layer are typically normal. EUS-FNA is the standard method by which a biopsy-proven diagnosis is obtained for most SEL's. However, the yield for a definite diagnosis from EUS-FNA for SELs is often suboptimal. Recently a new biopsy method, called "single incision needle-knife" (SINK) was introduced that may prove more useful in determining a definitive diagnosis. Furthermore, recent advances in core biopsy needles for EUS offer the hope for improved outcomes with EUS-guided fine-needle biopsy (FNB). However, it remains unclear whether superior diagnostic outcomes are obtained using the new SINK biopsy method or using new EUS-FNB core needles.

Conditions

• Disorder of Upper Gastrointestinal Tract
• Gastrointestinal Stromal Tumors
• Gastrointestinal Neoplasms

Interventions

PROCEDURE

EUS-guided fine needle biopsy

EUS-FNB is performed using a 22 or 25 G core biopsy needle (SharkCore FNB, Medtronic, Fridley, MN) by standard linear EUS-guided technique. The needle tip has six cutting edge surfaces and an opposing bevel to catch tissue as it is sheared off, enabling cohesive units of tissue acquisition with minimal tissue fracturing. 3 separate passes will be done into the lesion. Additional passes may be made if clinically necessary. No suction will be applied on the first pass. If the FNB sample obtained is deemed to be inadequate, negative pressure (using the standard suction syringe) will be applied to the needle on additional passes. The histology and cytology specimens will be processed as per standard clinical care.

PROCEDURE

Single incision needle knife biopsy

For patients allocated to the SINK group, after EUS confirmation, the esophagogastroduodenoscopy (EGD) will be repeated to perform the SINK biopsy. Under direct endoscopic visualization, a 10 mm linear incision will be made to the surface of the SEL using a conventional needle-knife sphincterotome with standard blended electrocautery (Endocut mode - ERBE system USA, Marietta, GA). A conventional biopsy forceps will then be introduced through the incision deep into the mass to obtain at least 3 samples. The incision will then be closed using 1 to 3 endoclips for prophylaxis against subsequent bleeding. The biopsies will be placed in formalin as per standard surgical pathology protocol.

Sponsors & Collaborators

• Unity Health Toronto

  lead OTHER

Principal Investigators

• Christopher Teshima, MD, PhD · Unity Health Toronto

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2018-04-30

Completion

2018-12-31

Countries

• Canada

Study Locations