Upper Gastrointestinal Wall ThickeningMM-EUS-UGIWTNCT07407296
Multimodal Endoscopic Ultrasound in the Evaluation of Indeterminate Upper Gastrointestinal Wall Thickening
An observational study of Upper Gastrointestinal Wall Thickening, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Wall Thickening
- What is being tested?
- Endoscopic ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
Read the 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).
- Conditions
- Upper Gastrointestinal Wall Thickening
- Being tested
- Endoscopic ultrasound
- Keywords
- Endoscopic Ultrasound in Upper Gastrointestinal Wall Thickening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasoundProcedure or surgery
Multimodal Endoscopic Ultrasound including; conventional B-mode EUS Assessment, doppler evaluation, EUS elastography and Selective EUS-Guided Fine-Needle Biopsy (EUS-FNB)
| Study group | Role | What they receive |
|---|---|---|
| Indeterminate Upper Gastrointestinal Wall Thickening | Not described Receives: Procedure: Endoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of multimodal EUS
Measured: one year
Secondary outcomes (3)
EUS imaging patterns associated with various etiologies.
Measured: one year
Incremental diagnostic value of elastography.
Measured: one year
Diagnostic yield of EUS-guided tissue acquisition.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal Wall ThickeningStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha Hussein Kawashty Abdelrahman, Assiut University
- Investigators
- Taha Hussein El-sherif, Principal investigator, Assit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407296
- Sponsor's protocol ID
- MM-EUS-UGIWT
- Acronym
- MM-EUS-UGIWT
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 1947313Tellez-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.
PubMed 31566322Macari 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.
PubMed 11312162Ergin 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.
PubMed 41011090Jung 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.
PubMed 27456608Chen 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.
PubMed 10389370Giri 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.
PubMed 38023968
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Endoscopic Ultrasound in the Evaluation of the Nature of Indeterminate Upper Gastrointestinal Wall Thickening
- ClinicalTrials.gov ID
- NCT07407296
- Acronym / sponsor ID
- MM-EUS-UGIWT / MM-EUS-UGIWT
- Conditions
- Upper Gastrointestinal Wall Thickening
- Keywords
- Endoscopic Ultrasound in Upper Gastrointestinal Wall Thickening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indeterminate Upper Gastrointestinal Wall Thickening | – | Procedure: Endoscopic ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasoundMultimodal Endoscopic Ultrasound including; conventional B-mode EUS Assessment, doppler evaluation, EUS elastography and Selective EUS-Guided Fine-Needle Biopsy (EUS-FNB) | Procedure or surgery | Indeterminate Upper Gastrointestinal Wall Thickening |
Primary outcome
Diagnostic accuracy of multimodal EUS
Time frame: one year
3 secondary outcomes
EUS imaging patterns associated with various etiologies.
Time frame: one year
Incremental diagnostic value of elastography.
Time frame: one year
Diagnostic yield of EUS-guided tissue acquisition.
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Results publication: PubMed 1947313Desai 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.
- Results publication: PubMed 31566322Tellez-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.
- Results publication: PubMed 11312162Macari 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.
- Results publication: PubMed 41011090Ergin 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.
- Results publication: PubMed 27456608Jung 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.
- Results publication: PubMed 10389370Chen 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.
- Results publication: PubMed 38023968Giri 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taha Hussein El-sherif principal investigator
Assit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Wall Thickening, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taha Hussein El-sherif (00201114236391 ext. 00201068012930, Elsheriftaha74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of multimodal EUS (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07407296, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.