NCT06748690 MCB vs EUS-FNA for Preoperative Pathological Evaluation of Gastric SMT
| NCT ID | NCT06748690 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Gastrointestinal Stromal Tumor of Stomach |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2024-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Gastrointestinal stromal tumors (GISTs) are the most common submucosal tumors (SMTs) of the stomach. The 2022 European Society of Oncology ESMO Diagnosis and Treatment Guidelines recommend that GISTs undergo biopsy with a clear pathological diagnosis and should be removed unless there are significant complications. But currently, the diagnostic rate of EUS-FNA for upper gastrointestinal subcutaneous lesions is less than 60%. In recent years, mucosal cutting biopsy (MCB) has become an effective method for diagnosing SMTs. Regardless of whether the SMTs are large or small, the application of MCB technology can quickly obtain pathological tissue under direct visualization, and its immunohistochemical pathological diagnosis rate is relatively satisfactory. MCB technology has great potential in the biopsy of SMTs, but there is currently no comparison of results between two technologies in randomized controlled trials. The purpose of this study is to design a randomized controlled trial to compare the diagnostic rates of EUS-FNA and MCB techniques for tissue pathology (including immunohistochemistry) of SMTs, in order to improve the diagnostic accuracy of SMTs in our hospital and improve patient prognosis.
Eligibility 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
Contact & Investigator
Liming Zhang, M.D.
STUDY CHAIR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06748690 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Stromal Tumor of Stomach. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06748690 currently recruiting?
Yes, NCT06748690 is actively recruiting participants. Contact the research team at zhaorui_001@126.com for enrollment information.
Where is the NCT06748690 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06748690 clinical trial?
NCT06748690 is sponsored by Peking University People's Hospital. The principal investigator is Liming Zhang, M.D. at Peking University People's Hospital. The trial plans to enroll 96 participants.