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

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ClinicalTrials.gov Identifier: NCT02866045
Recruitment Status : Unknown
Verified August 2016 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.


Condition or disease Intervention/treatment Phase
Disorder of Upper Gastrointestinal Tract Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Procedure: EUS-guided fine needle biopsy Procedure: Single incision needle knife biopsy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Endoscopic Ultrasonography Guided Fine Needle Biopsy (EUS-FNB) vs. Single-incision Needle-knife (SINK) Biopsy for Diagnosis of Upper Gastrointestinal Subepithelial Lesions
Study Start Date : May 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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.
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.
Other Name: EUS-FNB

Experimental: Single incision needle knife biopsy
SINK biopsy is performed under direct endoscopic visualization via EGD with a minimum of 3 biopsy samples obtained.
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.
Other Name: SINK




Primary Outcome Measures :
  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). [ Time Frame: 24 months ]
    Percentage of patients in each group for whom the pathologist provides a definite histologic diagnosis based on the biopsy sample.


Secondary Outcome Measures :
  1. Adverse events with SINK biopsy vs. EUS-FNB [ Time Frame: 24 months ]
  2. Procedure time with SINK biopsy vs. EUS-FNB [ Time Frame: 24 months ]
  3. Proportion of patients receiving a definite OR suspicious diagnosis for gastrointestinal SELs using SINK biopsy vs. EUS-FNB [ Time Frame: 24 months ]
    Percentage of patients in each group for whom the pathologist provides a "definite" or "suspicious" histologic diagnosis based on the biopsy specimen.

  4. Proportion of patients for whom a mitotic rate may be calculated for gastrointestinal stromal tumors (GISTs) using SINK biopsy vs. EUS-FNB [ Time Frame: 24 months ]
    Percentage of patients in each group with a diagnosis of GIST for whom a mitotic rate may be calculated by the pathologist from the biopsy specimen.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866045


Contacts
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Contact: Christopher Teshima, MD, PhD 416-864-5646 teshimac@smh.ca

Locations
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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Christopher Teshima, MD, PhD    416-864-5646    teshimac@smh.ca   
Sub-Investigator: Gary May, MD         
Sub-Investigator: Jeff Mosko, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Christopher Teshima, MD, PhD St. Michael's Hospital, Toronto

Publications:
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02866045     History of Changes
Other Study ID Numbers: 16-030
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Michael's Hospital, Toronto:
Subepithelial lesions
Endoscopic Ultrasound-Guided Fine Needle Aspiration

Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site