NCT06748690Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 19 Dec 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06748690
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 1 Jan 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with portal hypertension
- Patients with a history of upper gastrointestinal surgery
Lab values
- The patient has uncorrectable coagulation dysfunction (International Normalized Ratio (INR)\>1.5 or platelet count\<50x109)
Other
- 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
- Pregnant women
- Patients who refuse to participate in this clinical trial
Who the study is looking for
- Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.