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

NCT06748690 | Recruiting DMC

• 1 other identifier: RDL-13
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumor of Stomach; Submucosal Tumor of Stomach

Outcome Measures

Primary Outcomes (1)

• Pathological diagnosis and immunohistochemical diagnosis

  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.

  Pathological evaluation should be conducted immediately after specimen isolation

Study Arms (2)

MCB group

EXPERIMENTAL

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.

Procedure: mucosal cutting biopsy

EUS-FNA group

ACTIVE COMPARATOR

Using standard Endoscopic Ultrasonography-Guided Fine-Needle Aspiration(EUS-FNA) technology, using endoscopic ultrasound scanning to locate lesions, and puncture needle aspiration biopsy.

Procedure: endoscopic ultrasound-guided-fine needle aspiration

Interventions

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. (

MCB group

endoscopic ultrasound-guided-fine needle aspiration PROCEDURE

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.

EUS-FNA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (3)

• Dhaliwal A, Kolli S, Dhindsa BS, Devani K, Ramai D, Sayles H, Rangray R, Bhat I, Singh S, Adler DG. Clinical efficacy and safety of mucosal incision-assisted biopsy for the diagnosis of upper gastrointestinal subepithelial tumors: A systematic review and meta-analysis. Ann Gastroenterol. 2020 Mar-Apr;33(2):155-161. doi: 10.20524/aog.2020.0460. Epub 2020 Feb 14.

  PMID: 32127736 RESULT

• Fernandez-Esparrach G, Sendino O, Sole M, Pellise M, Colomo L, Pardo A, Martinez-Palli G, Arguello L, Bordas JM, Llach J, Gines A. Endoscopic ultrasound-guided fine-needle aspiration and trucut biopsy in the diagnosis of gastric stromal tumors: a randomized crossover study. Endoscopy. 2010 Apr;42(4):292-9. doi: 10.1055/s-0029-1244074. Epub 2010 Mar 30.

  PMID: 20354939 RESULT

• Sanaei O, Fernandez-Esparrach G, De La Serna-Higuera C, Carrara S, Kumbhari V, El Zein MH, Ismail A, Gines A, Sendino O, Montenegro A, Repici A, Rahal D, Brewer Gutierrez OI, Moran R, Yang J, Parsa N, Paiji C, Aghaie Meybodi M, Shin EJ, Lennon AM, Kalloo AN, Singh VK, Canto MI, Khashab MA. EUS-guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions: a randomized controlled trial. Endosc Int Open. 2020 Mar;8(3):E266-E273. doi: 10.1055/a-1075-1900. Epub 2020 Feb 21.

  PMID: 32118100 RESULT

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Liming Zhang, M.D.

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Rui Zhao, M.D.

CONTACT

8615611599955; zhaorui_001@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Endoscopy center, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)