Clinical trial NCT06748690: MCB vs EUS-FNA for Preoperative Pathological Evaluation of Gastric SMT
Official title: Comparison of Endoscopic Mucosal Cutting Biopsy and Endoscopic Ultrasound-guided-fine Needle Aspiration for Preoperative Pathological Evaluation of Gastric Submucosal Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Stromal Tumor of Stomach
Submucosal Tumor of Stomach
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pathological diagnosis and immunohistochemical diagnosis
timeFrame: Pathological evaluation should be conducted immediately after specimen isolation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Liming Zhang, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.