Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06748690

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

Led by Peking University People's Hospital · Updated on 2026-04-16

96

Participants Needed

1

Research Sites

156 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

R

Rui Zhao, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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