EUS-CNB Versus EUS-SINK for Diagnosis of Upper Gastrointestinal (UGI) Subepithelial Tumors



Status:Terminated
Healthy:No
Age Range:18 - 100
Updated:10/11/2018
Start Date:July 2014
End Date:November 2017

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EUS-guided Core Needle Biopsy (EUS-CNB) Versus EUS-guided Single-incision With Needle Knife (SINK) for the Diagnosis of Upper Gastrointestinal Subepithelial Lesions - a Multicenter Randomized Controlled Trial

This is a single-blinded randomized control trial trying to compare the effectiveness of
diagnosis between two techniques employed in tissue sampling for subepithelial tumors (SETs)
of the gastrointestinal tract. Over 2 years, patients having SET will be randomized to either
get the EUS-guided core needle biopsy (EUS-CNB) or EUS-guided single-incision with needle
knife (SINK) technique. This is of grave importance because the diagnosis of the myriad types
of SETs is made histologically requiring a good sample.

Upper gastrointestinal (GI) subepithelial tumors (SETs) are tumors arising from subepithelial
layers of esophageal, gastric or duodenal wall, mostly from the submucosa and muscular layer.
The incidence of SETs on routine endoscopy is 0.36% The differential diagnosis of SETs
include, though are not limited to: lipoma, leiomyoma, aberrant pancreas, varices, carcinoid,
gastrointestinal stromal tumors (GISTs), and lymphomas . Therefore, a correct diagnosis of
these tumors is important to guide subsequent management. These lesions are often not
accurately diagnosed on cross-sectional imaging . Endoscopic ultrasound (EUS) aids in
narrowing the differential diagnosis of the lesion as it is often able to establish the layer
of origin . However, an accurate diagnosis and targeted therapy is not made solely on the
morphological features but on histologic type and at times mitotic index. Thus the need for
techniques to obtain histology is beneficial in guiding management.

Since standard endoscopy with pinch biopsies of the overlying mucosa often fails to provide
an adequate sample for analysis, multiple other modalities to sample the lesion have been
utilized: EUS-guided fine needle aspiration (EUS-FNA), EUS-guided core needle biopsy
(EUS-CNB), bite-on-bite forceps biopsies, EUS-guided single-incision with needle knife (SINK)
and endoscopic resection.

EUS-FNA is now considered to be the usual method of sampling; however, the diagnostic yield
is low: 38% to 82% . Moreover, EUS-FNA often provides insufficient specimens which may not
allow for immunohistochemistry that is often essential for diagnosis . Thus EUS-CNB has been
assessed for the purpose of obtaining a core sample which allows for histological assessment.
Published data reveals a diagnostic (though not histologic) yield using EUS-CNB of 75% In
2011, the SINK technique for sampling was presented with a reported diagnostic accuracy of
92.8% [8]. The technique utilizes a conventional needle-knife connected to an electrosurgical
unit. A 6 to 12-mm mucosal incision is made over the lesion. Then conventional biopsy forceps
are introduced to obtain 3-5 samples. Subsequently, the incision is closed with 2 to 3
endoclips.

The purpose of this study is to prospectively compare the efficacy and safety of EUS-CNB with
SINK in patients with upper GI SETs. The investigators hypothesis is that the SINK technique
will be superior to the EUS-CNB in obtaining a histological specimen. The results of the
study would provide data which may improve the diagnostic ability for SETs. This in turn will
guide appropriate surveillance or management (surgical or endoscopic) for patients with these
lesions.

Inclusion Criteria:

- Patients referred for EUS evaluation of upper GI SETs measuring an estimated 15mm or
greater in maximal diameter.

- Location of SET: esophagus, stomach, duodenum

- Age >18 years and older

- Patient consent obtained

Exclusion Criteria:

- Endoscopically non bulging lesion

- Upper GI SETs <15 mm in size as measured during study EUS

- Lesions not necessitating tissue acquisition: i.e. lipomas, varices

- Cystic lesion

- Patients < 18 years of age

- Uncorrectable Coagulopathy (INR >1,5, platelets <100,000)

- Patients with stigmata of portal hypertension

- Patients with post-surgical UGI anatomy (Roux-en-Y gastric bypass, esophagectomy etc)

- Uncooperative patients

- Pregnant women (women of childbearing age will undergo urine pregnancy testing, which
is routine for all endoscopic procedures)

- Refusal to consent form
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Baltimore, Maryland 21287
410-955-5000
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