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

Stopped early · Not applicable

Conditions studied: Esophageal Subepithelial Lesions

In brief

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.

Key facts

Study ID

NCT02282111

Run by

Johns Hopkins University

People needed

56

Starts

2014-07-01

Expected to finish

2017-11-01

Last updated by the study team

2018-10-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.