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

NCT02866045 | Unknown Phase 3

• 1 other identifier: 16-030
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Subepithelial lesions; Endoscopic Ultrasound-Guided Fine Needle Aspiration

Outcome Measures

Primary Outcomes (1)

• Proportion of patients receiving a definitive histologic diagnosis for gastrointestinal SELs by single incision needle-knife biopsy (SINK biopsy) vs. EUS-guided fine needle biopsy (EUS-FNB).

  Percentage of patients in each group for whom the pathologist provides a definite histologic diagnosis based on the biopsy sample.

  24 months

Secondary Outcomes (4)

• Adverse events with SINK biopsy vs. EUS-FNB

  24 months

• Procedure time with SINK biopsy vs. EUS-FNB

  24 months

• Proportion of patients receiving a definite OR suspicious diagnosis for gastrointestinal SELs using SINK biopsy vs. EUS-FNB

  24 months

• Proportion of patients for whom a mitotic rate may be calculated for gastrointestinal stromal tumors (GISTs) using SINK biopsy vs. EUS-FNB

  24 months

Study Arms (2)

EUS-guided Fine Needle Biopsy

ACTIVE COMPARATOR

EUS-FNB is performed using a 22 or 25 G SharkCore biopsy needle with a minimum of 3 passes into the lesion.

Procedure: EUS-guided fine needle biopsy

Single incision needle knife biopsy

EXPERIMENTAL

SINK biopsy is performed under direct endoscopic visualization via EGD with a minimum of 3 biopsy samples obtained.

Procedure: Single incision needle knife biopsy

Interventions

EUS-guided fine needle biopsy PROCEDURE

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.

Also known as: EUS-FNB

EUS-guided Fine Needle Biopsy

Single incision needle knife biopsy PROCEDURE

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.

Also known as: SINK

Single incision needle knife biopsy

Eligibility Criteria

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

You may qualify if:

• Undergoing diagnostic endoscopy for gastrointestinal SELs
• Tumor size ≥ 15 mm with endoscopically visible bulge
• SELs in esophagus, stomach, or duodenum
• Ability to sign the informed consent for diagnostic procedure

You may not qualify if:

• Lesions not requiring pathological evaluation (e.g. lipoma, cyst, varices)
• Underlying medical condition that contraindicates diagnostic endoscopy.
• Bleeding diathesis
• Inability to sign the informed consent.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (2)

• de la Serna-Higuera C, Perez-Miranda M, Diez-Redondo P, Gil-Simon P, Herranz T, Perez-Martin E, Ochoa C, Caro-Paton A. EUS-guided single-incision needle-knife biopsy: description and results of a new method for tissue sampling of subepithelial GI tumors (with video). Gastrointest Endosc. 2011 Sep;74(3):672-6. doi: 10.1016/j.gie.2011.05.042.

  PMID: 21872716 BACKGROUND

• Mekky MA, Yamao K, Sawaki A, Mizuno N, Hara K, Nafeh MA, Osman AM, Koshikawa T, Yatabe Y, Bhatia V. Diagnostic utility of EUS-guided FNA in patients with gastric submucosal tumors. Gastrointest Endosc. 2010 May;71(6):913-9. doi: 10.1016/j.gie.2009.11.044. Epub 2010 Mar 11.

  PMID: 20226456 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms by Site

Study Officials

• Christopher Teshima, MD, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Teshima, MD, PhD

CONTACT

416-864-5646; teshimac@smh.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 15, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)