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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Rui Zhao, M.D.
zhaorui_001@126.com
8615611599955
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 96
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov