RecruitingNot ApplicableNCT06748690

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

Comparison of Endoscopic Mucosal Cutting Biopsy and Endoscopic Ultrasound-guided-fine Needle Aspiration for Preoperative Pathological Evaluation of Gastric Submucosal Tumors


Sponsor

Peking University People's Hospital

Enrollment

96 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods for taking a tissue sample from growths found beneath the stomach lining (called submucosal tumors): a standard technique called EUS-FNA (guided needle biopsy using ultrasound) versus a newer method called mucosal clip biopsy (MCB). The goal is to find out which method gives more accurate results before surgery. **You may be eligible if...** - You have a stomach submucosal tumor (a growth under the stomach lining) that is at least 15mm in size on endoscopy **You may NOT be eligible if...** - Your growth is smaller than 15mm - The growth does not need a tissue sample (e.g., it is clearly a fatty lump, varicose vein, or cyst) - You have a bleeding disorder or abnormal blood clotting - You have portal hypertension (high blood pressure in the liver's blood vessels) - You have had previous upper stomach surgery - You are pregnant - You decline to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREmucosal cutting biopsy

Under intravenous anesthesia, the patient inserted a gastroscopy (Olympus GIF-260J) through the mouth and used a disposable high-frequency cutting knife to cut open the surface mucosa of the tumor. Biopsy forceps were used to extract tissue that could 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. (

PROCEDUREendoscopic ultrasound-guided-fine needle aspiration

2\) EUS-FNA group: Standard (Endoscopic Ultrasonography-Guided Fine-Needle Aspiration) EUS-FNA technology was used, and electronic linear array ultrasound endoscopy (GF-UCT-260, Olympus, Japan) was used to scan and locate the lesion. Puncture needle (Boston Scientific, USA) was used for aspiration biopsy. The thickness of the puncture needle depends on the size, hardness, and location of the tumor.


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06748690