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

Peking University

Status: Enrolling

Conditions: Submucosal Tumor of Stomach; Gastrointestinal Stromal Tumor of Stomach

Treatments: Procedure: mucosal cutting biopsy; Procedure: endoscopic ultrasound-guided-fine needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT06748690

RDL-13

Details and patient eligibility

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

MCB group

Experimental group

Description:

Use a disposable high-frequency cutting knife under endoscopy to cut open the surface mucosa of the tumor, and use biopsy forceps to extract tissue that can be fully evaluated for pathological examination. Use a disposable hemostatic clip to suture the mucosal incision, and after thorough observation of the hemostasis, withdraw from the endoscope.

Treatment:

Procedure: mucosal cutting biopsy

EUS-FNA group

Active Comparator group

Description:

Using standard Endoscopic Ultrasonography-Guided Fine-Needle Aspiration(EUS-FNA) technology, using endoscopic ultrasound scanning to locate lesions, and puncture needle aspiration biopsy.

Treatment:

Procedure: endoscopic ultrasound-guided-fine needle aspiration