Clinical trial · Interventional
EUS-CNB Versus EUS-SINK for Diagnosis of Upper Gastrointestinal (UGI) Subepithelial Tumors
EUS-guided Core Needle Biopsy (EUS-CNB) Versus EUS-guided Single-incision With Needle Knife (SINK) for the Diagnosis of Upper Gastrointestinal Subepithelial Lesions - a Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Equality of results between the two groups at interim analysis
Summary
Brief summary (as posted)
This is a single-blinded randomized control trial trying to compare the effectiveness of diagnosis between two techniques employed in tissue sampling for subepithelial tumors (SETs) of the gastrointestinal tract. Over 2 years, patients having SET will be randomized to either get the EUS-guided core needle biopsy (EUS-CNB) or EUS-guided single-incision with needle knife (SINK) technique. This is of grave importance because the diagnosis of the myriad types of SETs is made histologically requiring a good sample.
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 |
|---|---|---|---|
| Esophageal Subepithelial Lesions | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC) | Device | — | UNRESOLVED |
| conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS-CNB
- description
- Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that the procedure terminated.
- interventionNames
- Device: 22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC)
- type
- ACTIVE_COMPARATOR
- label
- SINK
- description
- Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
- interventionNames
- Device: conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients referred for EUS evaluation of upper GI SETs measuring an estimated 15mm or greater in maximal diameter. * Location of SET: esophagus, stomach, duodenum * Age \>18 years and older * Patient consent obtained Exclusion Criteria: * Endoscopically non bulging lesion * Upper GI SETs \<15 mm in size as measured during study EUS * Lesions not necessitating tissue acquisition: i.e. lipomas, varices * Cystic lesion * Patients \< 18 years of age * Uncorrectable Coagulopathy (INR \>1,5, platelets \<100,000) * Patients with stigmata of portal hypertension * Patients with post-surgical UGI anatomy (Roux-en-Y gastric bypass, esophagectomy etc) * Uncooperative patients * Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures) * Refusal to consent form
References
Publications (0)
Data not yet available