Status:
TERMINATED
EUS-CNB Versus EUS-SINK for Diagnosis of Upper Gastrointestinal (UGI) Subepithelial Tumors
Lead Sponsor:
Johns Hopkins University
Conditions:
Esophageal Subepithelial Lesions
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 gastrointes...
Detailed Description
Upper gastrointestinal (GI) subepithelial tumors (SETs) are tumors arising from subepithelial layers of esophageal, gastric or duodenal wall, mostly from the submucosa and muscular layer. The incidenc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02282111
Start Date
July 1 2014
End Date
November 1 2017
Last Update
October 9 2018
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287