Multimodal Endoscopic Ultrasound in the Evaluation of Indeterminate Upper Gastrointestinal Wall Thickening (MM-EUS-UGIWT)

February 6, 2026 updated by: Taha Hussein Kawashty Abdelrahman, Assiut University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Egypt
      • Asyut, Egypt, Egypt, 71515
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Indeterminate Upper Gastrointestinal Wall Thickening
Procedure: Endoscopic ultrasound
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Diagnostic accuracy of multimodal EUS
Time Frame: one year
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Taha Hussein El-sherif, Assit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MM-EUS-UGIWT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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