Comparison of Endoscopic Mucosal Cutting Biopsy and Endoscopic Ultrasound-guided-fine Needle Aspiration for Preoperative Pathological Evaluation of Gastric Submucosal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pathological diagnosis and immunohistochemical diagnosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm
排除标准
- •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
研究组 & 干预措施
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.
干预措施: mucosal cutting biopsy (Procedure)
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.
干预措施: endoscopic ultrasound-guided-fine needle aspiration (Procedure)
结局指标
主要结局
Pathological diagnosis and immunohistochemical diagnosis
时间窗: Pathological evaluation should be conducted immediately after specimen isolation
Comparison of diagnostic yield between Mucosal Cutting Biopsy (MCB) and Endoscopic Ultrasonography-Guided Fine-Needle Aspiration (EUS-FNA) The diagnostic yield was defined as the percentage of lesions confirmed by a pathologic diagnosis involving immunohistological analysis.
次要结局
未报告次要终点
研究者
Zhang Liming
Director, Head of Endoscopy center, Principal Investigator, Clinical Professor
Peking University People's Hospital