Gastrointestinal Stromal Tumor of Stomach, Submucosal Tumor of Stomach
Conditions
Brief 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.
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological diagnosis and immunohistochemical diagnosis | 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. |
Countries
China
Contacts
CONTACTRui Zhao, M.D.
STUDY_CHAIRLiming Zhang, M.D.
Peking University People's Hospital
Outcome results
None listed