EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors
NCT ID: NCT02025244
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
52 participants
INTERVENTIONAL
2010-11-30
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Key Hole Biopsy
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
Key Hole Biopsy ( KHB)
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
EUS-FNA
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine mitotic activity is evaluated. In case of failure of this method, the second one is performed.
EUS-FNA
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
Key Hole Biopsy ( KHB)
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
EUS-FNA
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine mitotic activity is evaluated. In case of failure of this method, the second one is performed.
Interventions
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Key Hole Biopsy ( KHB)
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
EUS-FNA
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine mitotic activity is evaluated. In case of failure of this method, the second one is performed.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients younger than 18 years
* Coagulopathy (INR \> 1,5, platelets \< 100)
* Tumor size \< 20mm
18 Years
95 Years
ALL
No
Sponsors
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Vitkovice Hospital
OTHER
Responsible Party
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Vincent Zoundjiekpon
MD
Principal Investigators
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Vincent Zoundjiekpon, MD
Role: PRINCIPAL_INVESTIGATOR
Vitkovice Hospital
Locations
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Digestive Diseases Center, Vitkovice Hospital
Ostrava, Ostrava, Czechia
Digestive Diseases Center, Vitkovice Hospital
Ostrava, Ostrava, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Zoundjiekpon V, Falt P, Fojtik P, Kundratova E, Mikolajek O, Hanousek M, Reiterova K, Ziak D, Bolek M, Tchibozo A, Kliment M, Urban O. Endosonography-Guided Fine-Needle Aspiration versus "Key-Hole Biopsy" in the diagnostics of upper gastrointestinal subepithelial tumors. A prospective randomized interventional study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Mar;164(1):63-70. doi: 10.5507/bp.2019.013. Epub 2019 Apr 17.
Other Identifiers
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DDC VN 05
Identifier Type: -
Identifier Source: org_study_id