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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastrointestinal Stromal Tumor of Stomach Submucosal Tumor of Stomach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MCB group

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.

Group Type EXPERIMENTAL

mucosal cutting biopsy

Intervention Type PROCEDURE

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.

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EUS-FNA group

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

Group Type ACTIVE_COMPARATOR

endoscopic ultrasound-guided-fine needle aspiration

Intervention Type PROCEDURE

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.

Interventions

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mucosal 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.

(

Intervention Type PROCEDURE

endoscopic 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No