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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    96
  • sponsor
    Peking University People's Hospital
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Updated on 7 May 2025
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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.

Details
Condition Gastrointestinal Stromal Tumor of Stomach, Submucosal Tumor of Stomach
Age 18years or above
Clinical Study IdentifierNCT06748690
SponsorPeking University People's Hospital
Last Modified on7 May 2025

Eligibility

 Yes No Not Sure

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
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