Other Specified Disorders of Esophagus, Stomach or Duodenum Clinical Trial
Official title:
Endosonography-Guided Fine-Needle-Aspiration (EUS-FNA) Versus Key Hole Biopsy (KHB) in Diagnostics of Upper Gastrointestinal Submucosal Tumors - a Randomized Trial
Upper Gastrointestinal Submucosal Tumors are tumors arising from subepithelial layers of esophageal, gastric or duodenal wall. They usually have an intact mucosa lining on the inner surface. The prognosis and treatment of these tumors depend on their correct diagnostics and mitotic activity in case of Gastrointestinal Stromal Tumors (GIST). A standard forceps biopsy of mucosa is usually not helpful. Therefore, biopsy techniques capable of reaching deeper layer of Upper GUT are needed. The investigators compare KHB and EUS-FNA in the diagnostics of Upper gastrointestinal Submucosal Tumors.
Patients with endoscopically detected submucosal tumors of Upper GUT with diameter ≥ 2cm are
enrolled in the trial.
According to randomization, the patients are allocated to either EUS-FNA by 22G needle or
KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with
subsequent histological/cytological and immunohistochemical evaluation of the specimen. The
success of tissue diagnostics was evaluated as well as the possibility to determine the
mitotic activity in case of GIST. In case of failure of the initial method, the other method
was performed (cross-over design). Patients are hospitalized and kept under observation
during 24 hours after the biopsy.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic