Clinical trial · Interventional
EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors
Endosonography-Guided Fine-Needle-Aspiration (EUS-FNA) Versus Key Hole Biopsy (KHB) in Diagnostics of Upper Gastrointestinal Submucosal Tumors - a Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Other Specified Disorders of Esophagus, Stomach or Duodenum | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-FNA | Procedure | — | UNRESOLVED |
| Key Hole Biopsy ( KHB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Key Hole Biopsy
- description
- 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.
- interventionNames
- Procedure: Key Hole Biopsy ( KHB)
- Procedure: EUS-FNA
- type
- ACTIVE_COMPARATOR
- label
- EUS-FNA
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZoundjiekpon 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. PMID 31025658