EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors
Conditions
Other Specified Disorders of Esophagus, Stomach or Duodenum
Conditions: official terms
Esophageal Diseases
Conditions: Keywords
Key hole biopsy, Upper Gastrointestinal Submucosal Tumors, EUS-FNA, Mitototic Activity, GIST
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Intervention
Name: Key Hole Biopsy ( KHB) Type: Procedure
Name: EUS-FNA Type: Procedure
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 95 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Submucosal tumor with endoscopically normal intact mucosa

- Tumor size: 20mm or more

- Localization of tumors: esophagus,stomach, duodenum

- Age: 18 years and older

- The patient´s consent with a diagnostic procedure .

Exclusion Criteria:

- Endoscopically nonbuilding tumor

- Patients younger than 18 years

- Coagulopathy (INR > 1,5, platelets < 100)

- Tumor size < 20mm
Locations
Digestive Diseases Center, Vitkovice Hospital
Ostrava, Czech Republic
Status: Recruiting
Digestive Diseases Center, Vitkovice Hospital
Ostrava, Czech Republic
Status: Recruiting
Contact: Vincent Zoundjiekpon, MD - 00420608080209 - vincent04@post.cz
Start Date
November 2010
Completion Date
December 2015
Sponsors
Vitkovice Hospital
Source
Vitkovice Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page