Clinical trial · Interventional
EUS-FNB vs. Single-incision Needle-knife (SINK) Biopsy for Gastrointestinal SELs
Endoscopic Ultrasonography Guided Fine Needle Biopsy (EUS-FNB) vs. Single-incision Needle-knife (SINK) Biopsy for Diagnosis of Upper Gastrointestinal Subepithelial Lesions
- 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)
Sub epithelial lesions (SELs) of the gastrointestinal (GI) tract are commonly identified during routine endoscopy. Most of these lesions are benign. However because there is the potential for malignant transformation it is important to correctly identify the lesion in order to determine if any further therapy and/or surveillance is necessary for the patient, particularly for gastrointestinal stromal tumors (GISTs). Obtaining a definitive diagnosis for SELs is often difficult since biopsies of the normal overlying surface mucosal layer are typically normal. EUS-FNA is the standard method by which a biopsy-proven diagnosis is obtained for most SEL's. However, the yield for a definite diagnosis from EUS-FNA for SELs is often suboptimal. Recently a new biopsy method, called "single incision needle-knife" (SINK) was introduced that may prove more useful in determining a definitive diagnosis. Furthermore, recent advances in core biopsy needles for EUS offer the hope for improved outcomes with EUS-guided fine-needle biopsy (FNB). However, it remains unclear whether superior diagnostic outcomes are obtained using the new SINK biopsy method or using new EUS-FNB core needles.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disorder of Upper Gastrointestinal Tract | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided fine needle biopsy | Procedure | — | UNRESOLVED |
| Single incision needle knife biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS-guided Fine Needle Biopsy
- description
- EUS-FNB is performed using a 22 or 25 G SharkCore biopsy needle with a minimum of 3 passes into the lesion.
- interventionNames
- Procedure: EUS-guided fine needle biopsy
- type
- EXPERIMENTAL
- label
- Single incision needle knife biopsy
- description
- SINK biopsy is performed under direct endoscopic visualization via EGD with a minimum of 3 biopsy samples obtained.
- interventionNames
- Procedure: Single incision needle knife biopsy
Primary outcomes (1)
- measure
- Proportion of patients receiving a definitive histologic diagnosis for gastrointestinal SELs by single incision needle-knife biopsy (SINK biopsy) vs. EUS-guided fine needle biopsy (EUS-FNB).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Undergoing diagnostic endoscopy for gastrointestinal SELs * Tumor size ≥ 15 mm with endoscopically visible bulge * SELs in esophagus, stomach, or duodenum * Ability to sign the informed consent for diagnostic procedure Exclusion Criteria: * Lesions not requiring pathological evaluation (e.g. lipoma, cyst, varices) * Underlying medical condition that contraindicates diagnostic endoscopy. * Bleeding diathesis * Inability to sign the informed consent.
References
Publications (2)
- BACKGROUNDde la Serna-Higuera C, Perez-Miranda M, Diez-Redondo P, Gil-Simon P, Herranz T, Perez-Martin E, Ochoa C, Caro-Paton A. EUS-guided single-incision needle-knife biopsy: description and results of a new method for tissue sampling of subepithelial GI tumors (with video). Gastrointest Endosc. 2011 Sep;74(3):672-6. doi: 10.1016/j.gie.2011.05.042. PMID 21872716
- BACKGROUNDMekky MA, Yamao K, Sawaki A, Mizuno N, Hara K, Nafeh MA, Osman AM, Koshikawa T, Yatabe Y, Bhatia V. Diagnostic utility of EUS-guided FNA in patients with gastric submucosal tumors. Gastrointest Endosc. 2010 May;71(6):913-9. doi: 10.1016/j.gie.2009.11.044. Epub 2010 Mar 11. PMID 20226456