Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06748690

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Liming Zhang, M.D.

CONTACT

[email protected]

8613671027761

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mucosal cutting biopsy

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.

(

endoscopic ultrasound-guided-fine needle aspiration

Procedure
  • 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.

Primary outcomes

  1. Pathological diagnosis and immunohistochemical diagnosis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rui Zhao, M.D.

CONTACT

[email protected]

8615611599955

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.