Recruiting
Phase 3

SINK vs. EUS-FNB

Sponsor:

Unity Health Toronto

Code:

NCT02866045

Conditions

Disorder of Upper Gastrointestinal Tract

Gastrointestinal Stromal Tumors

Gastrointestinal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EUS-guided fine needle biopsy

Single incision needle knife biopsy

Study Details

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

Study ID

NCT02866045

Start date

May, 2016

Status verified date

Aug, 2016

Completion date

Dec, 2018

Anticipated

Primary completion date

Apr, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: EUS-guided Fine Needle Biopsy

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

experimental: Single incision needle knife biopsy

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

Interventions

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.

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.

Primary outcome measure

  • 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). [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Christopher Teshima, MD, PhD

416-864-5646teshimac@smh.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Christopher Teshima, MD, PhD

416-864-5646teshimac@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Aug 15, 2016

Last verified

Aug, 2016

Keywords

  • Subepithelial lesions
  • Endoscopic Ultrasound-Guided Fine Needle Aspiration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2016-08-15.