Comparing two biopsy methods for diagnosing stomach tumors
Official title: Comparison of Endoscopic Mucosal Cutting Biopsy and Endoscopic Ultrasound-guided-fine Needle Aspiration for Preoperative Pathological Evaluation of Gastric Submucosal Tumors
Run by Peking University People's Hospital · NCT06748690 · Data updated 2026-11-12
This study is testing which biopsy method works better for diagnosing stomach tumors in patients with larger growths to help doctors make better treatment decisions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT06748690 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with gastric submucosal tumors that are 15mm or larger.
✕Probably not a fit
Patients with non-bulging lesions, cystic lesions, or those with coagulation dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of mucosal cutting biopsy (MCB) versus endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for the preoperative pathological evaluation of gastrointestinal stromal tumors (GISTs) and other submucosal tumors (SMTs) of the stomach. The study will involve patients with gastric SMTs that are 15mm or larger, as recommended by the European Society of Oncology guidelines. By utilizing a randomized controlled trial design, the researchers hope to determine which biopsy method provides a higher diagnostic rate and better pathological evaluation. This could lead to improved treatment decisions for patients with these tumors.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of preoperative diagnoses for gastric tumors, leading to better treatment outcomes.
How similar studies have gone: While MCB has shown promise in diagnosing SMTs, this study is novel as it directly compares MCB and EUS-FNA in a randomized controlled setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm Exclusion Criteria: * Endoscopic non bulging lesions. * The upper gastrointestinal lesions measured by Endoscopic Ultrasonography(EUS) are less than 15 mm. * Lesions that do not require tissue collection (such as lipomas, varicose veins) * Patients with cystic lesions * The patient has uncorrectable coagulation dysfunction (International Normalized Ratio (INR)\>1.5 or platelet count\<50x109) * Patients with portal hypertension * Patients with a history of upper gastrointestinal surgery * Pregnant women * Patients who refuse to participate in this clinical trial
Where it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Rui Zhao, M.D.
- Email: zhaorui_001@126.com
- Phone: 8615611599955
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.