Clinical trial · Interventional
Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy
- 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)
To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are required. It is difficult to obtain adequate tissue samples. There were several biopsy methods to obtain tissue samples. Pathological examination would include mitosis counts, particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall, where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor (GIST) of malignant potential is essential. So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and complications between EUS-FNB \& unroofing biopsy.
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 |
|---|---|---|---|
| Upper Gastrointestinal Subepithelial Tumors | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-FNB(endoscopic ultrasonography guided fine needle biopsy) | Procedure | — | UNRESOLVED |
| unroofing biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- unroofing biopsy
- interventionNames
- Procedure: unroofing biopsy
- type
- ACTIVE_COMPARATOR
- label
- EUS-FNB
- interventionNames
- Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)
Primary outcomes (1)
- measure
- diagnostic accuracy
- timeFrame
- within 7 days
- description
- We will compare between diagnostic accuracy of EUS-FNB \& unroofing biopsy using final histopathological result.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Older than 19 years old and younger than 80 years old * Suspected upper gastrointestinal subepithelial tumors(≥15mm, ≤35mm) that were originated from muscularis propria layer on endoscopic ultrasonography(EUS) Exclusion Criteria: * Patient who had bleeding tendency * Any previous surgery on esophagus, stomach or duodenum * Patients who can not be underwent sedated endoscopy * Gastrointestinal subepithelial tumor that was not origianted from muscularis propria layer on EUS * Constrast related allergic disease
References
Publications (1)
- DERIVEDPark J, Park JC, Jo JH, Kim EH, Shin SK, Lee SK, Lee YC. Prospective comparative study of endoscopic ultrasonography-guided fine-needle biopsy and unroofing biopsy. Dig Liver Dis. 2019 Jun;51(6):831-836. doi: 10.1016/j.dld.2019.01.028. Epub 2019 Feb 19. PMID 30872087