MCB vs EUS-FNA for Preoperative Pathological Evaluation of Gastric SMT

Recruiting now · Not applicable

Conditions studied: Gastrointestinal Stromal Tumor of Stomach, Submucosal Tumor of Stomach

In brief

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.

Key facts

Study ID

NCT06748690

Run by

Peking University People's Hospital

People needed

96

Starts

2024-01-01

Expected to finish

2026-12-31

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm

You may not qualify if…

• 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 is running

• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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