NCT07407296

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
28mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Feb 2026Dec 2028

Study Start

First participant enrolled

February 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

February 6, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

Endoscopic Ultrasound in Upper Gastrointestinal Wall Thickening

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of multimodal EUS

    one year

Secondary Outcomes (3)

  • EUS imaging patterns associated with various etiologies.

    one year

  • Incremental diagnostic value of elastography.

    one year

  • Diagnostic yield of EUS-guided tissue acquisition.

    one year

Study Arms (1)

Indeterminate Upper Gastrointestinal Wall Thickening

Procedure: Endoscopic ultrasound

Interventions

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

Indeterminate Upper Gastrointestinal Wall Thickening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt, 71515, Egypt

Location

Related Publications (7)

  • Desai R, Tagliabue J, Wegryn S, Einstein D. CT evaluation of wall thickening in the alimentary tract. Radiographics. 1991;11(5):771-83.

    RESULT
  • 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.

    RESULT
  • Macari M, Balthazar EJ. CT of bowel wall thickening: significance and pitfalls of interpretation. American Journal of Roentgenology. 2001;176(5):1105-16.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Taha Hussein El-sherif

    Assit University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taha Hussein El-sherif

CONTACT

Ahmed Radwan Riad

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent Lecturer at Tropical Medicine and Gastroenterology

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations