Comparing two biopsy methods for diagnosing stomach tumors
Comparison of Endoscopic Mucosal Cutting Biopsy and Endoscopic Ultrasound-guided-fine Needle Aspiration for Preoperative Pathological Evaluation of Gastric Submucosal Tumors
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06748690 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with gastric submucosal tumors that are 15mm or larger.
Not a fit: Patients with non-bulging lesions, cystic lesions, or those with coagulation dysfunction may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.