Multimodal Endoscopic Ultrasound in the Evaluation of Indeterminate Upper Gastrointestinal Wall Thickening

Официальное название

Multimodal Endoscopic Ultrasound in the Evaluation of the Nature of Indeterminate Upper Gastrointestinal Wall Thickening

Обзор

Multimodal endoscopic ultrasound can help to differentiate between benign (non-cancerous) and malignant (cancerous) causes of thickening of the upper digestive tract wall. The main questions this study aims to answer are: How accurate is multimodal endoscopic ultrasound in identifying the cause of upper digestive tract wall thickening? Can using several ultrasound techniques together improve diagnosis when standard tests are unclear? Participants are adults who have upper digestive tract wall thickening seen on scans such as computed tomography (CT) or magnetic resonance imaging (MRI). Participants will: Undergo upper endoscopy followed by endoscopic ultrasound and tissue sample taken during the procedure when needed followed by using biopsy results or clinical follow-up to confirm the final diagnosis This study aims to improve early and accurate diagnosis and help guide proper treatment decisions for people with unexplained upper digestive tract wall thickening.

Подробное описание

Upper gastrointestinal wall thickening (UGIT) refers to the abnormal increase in the thickness of the gastrointestinal wall, which can be observed in various clinical conditions, including both benign and malignant diseases (1).

Abnormal gastric wall thickening can be caused by a wide range of benign and malignant conditions, and expedient diagnosis is required to commence the appropriate treatment (2, 3).

Traditional diagnostic approaches for evaluating UGIT rely primarily on cross-sectional imaging techniques such as contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI). However, these modalities often lack sufficient spatial resolution to accurately characterize the individual layers of the gastrointestinal wall, particularly in cases of subtle mucosal or submucosal disease (4, 5).

Esophagogastroduodenoscopy (EGD) allows direct visualization of the mucosal surface and enables tissue sampling through conventional biopsies. Nevertheless, many pathological processes responsible for gastrointestinal wall thickening-such as gastric lymphoma, subepithelial tumors, linitis plastica, and infiltrative scirrhous carcinoma-originate in the deeper layers of the gastrointestinal wall (6).

EUS allows clear delineation of the gastrointestinal wall layers and surrounding structures. EUS-guided tissue acquisition using fine-needle biopsy (FNB) allows sampling of submucosal and muscular lesions that are inaccessible to conventional endoscopic biopsies (1).

Вмешательства

• Процедура Endoscopic ultrasound
  Multimodal Endoscopic Ultrasound including; conventional B-mode EUS Assessment, doppler evaluation, EUS elastography and Selective EUS-Guided Fine-Needle Biopsy (EUS-FNB)

Первичные конечные точки

• Diagnostic accuracy of multimodal EUS [Срок оценки: one year]

Вторичные конечные точки (3)

• EUS imaging patterns associated with various etiologies. [Срок оценки: one year]
• Incremental diagnostic value of elastography. [Срок оценки: one year]
• Diagnostic yield of EUS-guided tissue acquisition. [Срок оценки: one year]

Критерии участия

Критерии включения

• Age ≥18 years
• Patients with endoscopic or radiological (U/S, CT or MRI) evidence of upper GI wall thickening (esophagus, stomach, or duodenum) and defined based on established radiologic standards. A wall thickness by MSCT >5 mm in the oesophagus and stomach and >4 mm in the duodenum in accordance with accepted CT imaging criteria (4, 7).
• Written informed consent provided.

Критерии исключения

• Patient refusal or inability to provide informed consent
• Uncorrectable coagulation disorder e.g prothrombin concentration <60%, INR >1.5 or platelet count <50,000/µL that cannot be corrected pre-procedure according to institutional guidelines.
• Presence of contraindications for endoscopy/sedation.
• Known diagnosis explaining wall thickening prior to EUS.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Египет · 1 центр

• Assiut University — Asyut

Публикации

• Desai RK, Tagliabue JR, Wegryn SA, Einstein DM. CT evaluation of wall thickening in the alimentary tract. Radiographics. 1991 Sep;11(5):771-83; discussion 784. doi: 10.1148/radiographics.11.5.1947313. PMID 1947313
• Tellez-Avila FI, Duarte-Medrano G, Lopez-Arce G, Herrera-Mora D, Ramirez-Luna MA, Valdovinos-Andraca F, Elizondo-Rivera J. EUS-guided tissue samples for the diagnosis of patients with a thickened gastric wall and prior negative endoscopic biopsies. Acta Gastroenterol Belg. 2019 Jul-Sep;82(3):359-362. PMID 31566322
• Macari M, Balthazar EJ. CT of bowel wall thickening: significance and pitfalls of interpretation. AJR Am J Roentgenol. 2001 May;176(5):1105-16. doi: 10.2214/ajr.176.5.1761105. No abstract available. PMID 11312162
• Ergin M, Kivrakoglu F. Evaluation of Endoscopic Findings in Gastrointestinal Tract Wall Thickening Detected on Abdominal Radiological Imaging: A Two-Center Retrospective Descriptive Study. Medicina (Kaunas). 2025 Sep 18;61(9):1699. doi: 10.3390/medicina61091699. PMID 41011090
• Jung K, Park MI, Kim SE, Park SJ. Borrmann Type 4 Advanced Gastric Cancer: Focus on the Development of Scirrhous Gastric Cancer. Clin Endosc. 2016 Jul;49(4):336-45. doi: 10.5946/ce.2016.057. Epub 2016 Jul 25. PMID 27456608
• Chen TK, Wu CH, Lee CL, Lai YC, Yang SS. Endoscopic ultrasonography in the differential diagnosis of giant gastric folds. J Formos Med Assoc. 1999 Apr;98(4):261-4. PMID 10389370
• Giri S, Narayan J, Angadi S, Shah B, Ingle M, B K, Tyagi U, Kumar L, Wu CCH, Bhrugumalla S, Sundaram S. Role of endoscopic ultrasound-guided tissue acquisition for the diagnosis of gastric wall thickening: a retrospective study with meta-analysis. Ann Gastroenterol. 2023 Nov-Dec;36(6):605-614. doi: 10.20524/aog.2023.0831. Epub 2023 Nov 3. PMID 38023968

Идентификаторы

NCT: NCT07407296 · MM-EUS-UGIWT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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