Clinical trial NCT02025244: EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors
Official title: Endosonography-Guided Fine-Needle-Aspiration (EUS-FNA) Versus Key Hole Biopsy (KHB) in Diagnostics of Upper Gastrointestinal Submucosal Tumors - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Other Specified Disorders of Esophagus, Stomach or Duodenum
Keywords: Key hole biopsy
Upper Gastrointestinal Submucosal Tumors
EUS-FNA
Mitototic Activity
GIST
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility 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

Primary outcomes:
measure: To compare the yield and success of KHB and EUS-FNA in cytological / histological and immunohistochemical diagnostics of Upper Gastrointestinal Submucosal Tumors.
timeFrame: 5 years
Secondary outcomes:
measure: Detection of mitotic activity in case of Gastrointestinal Stromal Tumors
timeFrame: 5 years
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center, Vitkovice Hospital
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center, Vitkovice Hospital
Study officials:
affiliation: Vitkovice Hospital
name: Vincent Zoundjiekpon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.