- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407296
Multimodal Endoscopic Ultrasound in the Evaluation of Indeterminate Upper Gastrointestinal Wall Thickening (MM-EUS-UGIWT)
Multimodal Endoscopic Ultrasound in the Evaluation of the Nature of Indeterminate Upper Gastrointestinal Wall Thickening
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Taha Hussein El-sherif
- Phone Number: 00201068012930 00201114236391
- Email: Elsheriftaha74@gmail.com
Study Contact Backup
- Name: Ahmed Radwan Riad
- Phone Number: 00201126435001
- Email: Dr.Radwan@aun.edu.eg
Study Locations
-
-
Egypt
-
Asyut, Egypt, Egypt, 71515
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Indeterminate Upper Gastrointestinal Wall Thickening
|
Multimodal Endoscopic Ultrasound including; conventional B-mode EUS Assessment, doppler evaluation, EUS elastography and Selective EUS-Guided Fine-Needle Biopsy (EUS-FNB)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diagnostic accuracy of multimodal EUS
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
EUS imaging patterns associated with various etiologies.
Time Frame: one year
|
one year
|
|
Incremental diagnostic value of elastography.
Time Frame: one year
|
one year
|
|
Diagnostic yield of EUS-guided tissue acquisition.
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Taha Hussein El-sherif, Assit University
Publications and helpful links
General Publications
- Desai R, Tagliabue J, Wegryn S, Einstein D. CT evaluation of wall thickening in the alimentary tract. Radiographics. 1991;11(5):771-83.
- Téllez-Ávila F, Duarte-Medrano G, Lopez-Arce G, Herrera-Mora D, Ramírez-Luna M, Valdovinos-Andraca F, et al. EUS-guided tissue samples for the diagnosis of patients with a thickened gastric wall and prior negative endoscopic biopsies. Acta Gastro-Enterologica Belgica. 2019;82.
- Macari M, Balthazar EJ. CT of bowel wall thickening: significance and pitfalls of interpretation. American Journal of Roentgenology. 2001;176(5):1105-16.
- Ergin M, Kıvrakoğlu F. Evaluation of Endoscopic Findings in Gastrointestinal Tract Wall Thickening Detected on kAbdominal Radiological Imaging: A Two-Center Retrospective Descriptive Study. Medicina. 2025;61(9):1699.
- Jung K, Park MI, Kim SE, Park SJ. Borrmann type 4 advanced gastric cancer: focus on the development of scirrhous gastric cancer. Clinical endoscopy. 2016;49(4):336-45.
- Chen T, Wu C, Lee C, Lai Y, Yang S. Endoscopic ultrasonography in the differential diagnosis of giant gastric folds. Journal of the Formosan Medical Association= Taiwan yi zhi. 1999;98(4):261-4.
- Giri S, Narayan J, Angadi S, Shah B, Ingle M, Tyagi U, et al. Role of endoscopic ultrasound-guided tissue acquisition for the diagnosis of gastric wall thickening: a retrospective study with meta-analysis. Annals of Gastroenterology. 2023;36(6):605.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Cytological Techniques
- Biopsy
- Cytodiagnosis
- Diagnostic Techniques, Surgical
- Diagnostic Imaging
- Ultrasonography
- Biopsy, Fine-Needle
- Biopsy, Needle
- Image-Guided Biopsy
- Ultrasonography, Interventional
- Endoscopic Ultrasound-Guided Fine Needle Aspiration
Other Study ID Numbers
- MM-EUS-UGIWT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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