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

NCT02282111 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-10-09

Study results available
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Summary

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.

Conditions

  • Esophageal Subepithelial Lesions

Interventions

DEVICE

22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC)

Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that, the procedure terminated.

DEVICE

conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass)

Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.

Sponsors & Collaborators

Principal Investigators

  • Mouen Khashab, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282111 on ClinicalTrials.gov