Submucosal TumorNCT07106411
CEH-EUS for Differentiating GISTs and Leiomyomas: A Multicenter Prospective Self-Controlled Study
An observational study of Submucosal Tumor and Gastrointestinal Stromal Tumor (GIST), run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The investigators conduct a prospective, multicenter diagnostic trial primarily aimed at evaluating the value of contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) in differentiating gastrointestinal stromal tumors (GISTs) from leiomyomas, as well as its predictive utility in the risk stratification of GISTs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Submucosal Tumor, Gastrointestinal Stromal Tumor (GIST), Leiomyoma
- What is being tested?
- Endoscopic Ultrasound and Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Oct 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants aged 18-85 years with gastrointestinal subepithelial lesions identified by endoscopy, undergoing both EUS and CEH-EUS for diagnostic evaluation. Only patients with histologically confirmed GISTs or leiomyomas will be included.
Who may be able to join
- Age ≥18 years and ≤ 85 years;
- Subepithelial lesion in the gastrointestinal tract identified under white-light endoscopy and scheduled for CEH-EUS examination to determine the nature of the lesion;
- EUS image quality meets the following quality control standards:
- Equipment requirements: EU-ME2 processor (Olympus, Tokyo, Japan) and GF-UCT260 / GF-UE260 echoendoscope (Olympus, Tokyo, Japan);
- Image acquisition: Five EUS still images clearly displaying the lesion and surrounding structures, including maximum lesion diameter, originating layer, Doppler signals, and internal echo characteristics; a 15-second video clearly demonstrating the lesion without any artificial annotations (e.g., scale, needle, Doppler signal, elastography, etc.);
- CEH-EUS procedure: Use of extended pure harmonic detection (Ex-PHD) mode with mechanical index (MI) adjusted to 0.3; 2.4 mL of SonoVue contrast agent is injected via the elbow vein within 2-3 seconds, followed by a 5 mL saline flush; real-time dynamic image acquisition continues for 120 seconds, and video recording is collected.
- Patients with GIST confirmed by surgical or endoscopic resection pathology, and patients with leiomyoma confirmed by surgical resection, EUS-guided tissue sampling, or other biopsy techniques;
- Written informed consent is obtained.
Who cannot join
- Age <18 years or >85 years;
- Hemoglobin level ≤8.0 g/dL;
- Known allergy or hypersensitivity to ultrasound contrast agents;
- Pregnant women;
- Severe cardiopulmonary dysfunction that precludes tolerance of endoscopic ultrasound examination;
- Inability to provide written informed consent (e.g., due to psychiatric disorders or substance abuse).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Bin Cheng, 13986097542, b.cheng@tjh.tjmu.edu.cn
About this study
Official title: Contrast-Enhanced Harmonic Endoscopic Ultrasound for the Differential Diagnosis Between Gastrointestinal Stromal Tumors and Leiomyomas: A Multicenter Prospective Self-Controlled Study
The investigators conduct a prospective, multicenter diagnostic trial primarily aimed at evaluating the value of contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) in differentiating gastrointestinal stromal tumors (GISTs) from leiomyomas, as well as its predictive utility in the risk stratification of GISTs.
Read the detailed description
This study adopts a prospective, multicenter, self-controlled (pre-post) design. Patients with upper gastrointestinal subepithelial lesions (SELs) detected under white-light endoscopy will be consecutively enrolled. Each patient will first undergo endoscopic ultrasound (EUS) examination, during which lesion characteristics-including tumor size, margins, internal echogenicity, and originating layer-will be recorded. The contrast-specific extended pure harmonic detection (ExPHD) mode will then be activated, the mechanical index (MI) will be set to 0.3, and 2.4 mL of contrast agent (SonoVue) will be injected intravenously, followed by a 5 mL saline flush. Real-time dynamic imaging will be recorded for 120 seconds, capturing the arterial, venous, and delayed phases.
Histopathological results from surgical or endoscopic resection will serve as the reference standard. The diagnostic performance of EUS and contrast-enhanced EUS (CE-EUS) for differentiating gastrointestinal stromal tumors (GISTs) from leiomyomas and for predicting GIST risk stratification will be compared.
Patients meeting the inclusion criteria will be consecutively recruited. The primary outcome indicators are the sensitivity of CEH-EUS versus EUS in the differential diagnosis between GIST and leiomyoma, as well as in risk stratification of GIST. A prospective, self-controlled design will be used, with a type I error (α) of 0.05 (two-sided) and type II error (β) of 0.20, yielding a power of 0.80. Based on prior studies, the sensitivity of CEH-EUS for differentiating GISTs from leiomyomas is 87%, while that of EUS is approximately 72%-73%. Using McNemar's test for paired binary data (e.g., the same subject evaluated by two methods for positive diagnosis), the minimum sample size required for GIST patients is 121. Given that GISTs account for 67%-68% of all SELs, the required combined sample size of GIST and leiomyoma cases is 178. Accounting for an estimated 20% dropout rate, the final minimum sample size is 222 cases. For the GIST risk stratification analysis, prior studies report a sensitivity of 93% for CEH-EUS and 80% for EUS. McNemar's test was again used for sample size estimation. To meet the statistical requirements, 110 low-risk GIST cases are needed. Considering that low-risk GISTs comprise about 70% of all GISTs, and factoring in a 20% dropout rate, the total number of prospectively enrolled GIST patients required is 196. Since the risk stratification task requires a larger sample size and GISTs are the target of both diagnostic and stratification objectives, the final planned total sample size is 288 patients with GISTs or leiomyomas, which satisfies the statistical requirements for all primary study endpoints.
The study team will screen patients based on inclusion and exclusion criteria, ensure that all necessary examinations are completed to confirm eligibility, and obtain written informed consent from all prospective participants before conducting any study-related procedures.
This is a purely observational study. No additional interventions will be performed on participants, nor will they incur any extra costs. Patient access to optimal diagnostic or therapeutic options will not be affected. The primary potential risk is the breach of patient privacy. A strict data security and monitoring plan will be implemented, and participants will be informed that their data will be used for clinical research purposes.
The diagnostic performance of EUS and CE-EUS in differentiating GISTs from leiomyomas and in risk stratification of GISTs will be compared, with histopathological diagnosis serving as the gold standard. Diagnostic performance will be evaluated using paired analysis. All statistical tests will be two-sided, with significance defined as P < 0.05. Continuous variables will be presented as mean ± standard deviation, and categorical variables as counts and percentages.(1) Diagnostic performance: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the curve (AUC) will be calculated for both CEH-EUS and EUS as interpreted by expert endoscopists. To address class imbalance (e.g., GIST vs. other lesions), F1-score (harmonic mean) and balanced accuracy will also be computed. (2) Continuous variables: Comparisons with baseline will be performed using paired t-tests, analysis of variance (ANOVA), or rank-sum tests, as appropriate to data distribution. (3) Categorical variables: Group comparisons will use Chi-square tests (including Cochran-Mantel-Haenszel Chi-square) or Fisher's exact test. (4) Baseline comparability: Demographic and baseline characteristics will be compared using independent t-tests or Chi-square tests to assess balance between groups. (5) Effectiveness analysis: The primary effectiveness endpoint is the diagnostic accuracy for upper gastrointestinal subepithelial lesions. Differences in proportions and the Youden index will be compared using approximate Z-tests or Chi-square tests, with adjustment for center effects. (6) Statistical software: All statistical analyses will be performed using SPSS version 26.0.
- Being tested
- Endoscopic Ultrasound, Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)
- Keywords
- Endoscopic ultrasound, Contrast-Enhanced Ultrasonography
- Medical subject headings
- Gastrointestinal Stromal Tumors, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic UltrasoundDiagnostic test
Conventional EUS will be performed to evaluate lesion size, echogenicity, border, and layer of origin for differentiation between GISTs and leiomyomas and risk stratification of GISTs.
Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)Diagnostic test
CEH-EUS will be conducted using a contrast agent to assess vascularity and enhancement patterns of the lesion for differentiation between GISTs and leiomyomas and risk stratification of GISTs.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | All enrolled patients with upper gastrointestinal subepithelial lesions confirmed by histopathology. Each participant underwent both endoscopic ultrasound (EUS) and contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) examinations. Receives: Diagnostic Test: Endoscopic Ultrasound; Diagnostic Test: Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CE-EUS and EUS for differentiating GIST from leiomyoma
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.
Measured: Within 1 month after final histopathological diagnosis
Accuracy of CE-EUS and EUS in predicting malignant potential (risk stratification) of gastrointestinal stromal tumors
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.
Measured: Within 1 month after final histopathological diagnosis
Secondary outcomes (3)
Comparison of CEH-EUS Imaging Characteristics Between GIST and Leiomyoma
Contrast-enhancement patterns and perfusion characteristics will be recorded and compared between histologically confirmed GISTs and leiomyomas.
Measured: Within 1 month after histopathological diagnosis
Quantitative TIC Parameter Analysis for Differential Diagnosis and Risk Stratification
TIC-based quantitative CEH-EUS parameters will be measured and evaluated for their ability to distinguish GIST from leiomyoma and to predict GIST risk stratification, compared against final histopathology.
Measured: Within 1 month after histopathological diagnosis
Correlation of CEH-EUS Perfusion Parameters with Tumor Type and Risk Classification
CEH-EUS perfusion parameters such as enhancement intensity, wash-in rate, and wash-out rate will be analyzed for correlation with tumor type (GIST vs. leiomyoma) and with GIST risk levels based on NIH criteria.
Measured: Within 1 month after histopathological diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Submucosal TumorStudies of the same condition, open and under way.
- 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
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongnan Hospital, Wuhan Central Hospital
- Responsible party
- Principal investigator, Bin Cheng, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106411
- Sponsor's protocol ID
- CEH-EUS 2025
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abe K, Tominaga K, Yamamiya A, Inaba Y, Kanamori A, Kondo M, Suzuki T, Watanabe H, Kawano M, Sato T, Yoshitake N, Ohwada T, Konno M, Hanatsuka K, Masuyama H, Goda K, Haruyama Y, Irisawa A; NUTSHELL20 Study group. Natural History of Small Gastric Subepithelial Lesions Less than 20 mm: A Multicenter Retrospective Observational Study (NUTSHELL20 Study). Digestion. 2023;104(3):174-186. doi: 10.1159/000527421. Epub 2022 Dec 5.
PubMed 36470211Li J, Ye Y, Wang J, Zhang B, Qin S, Shi Y, He Y, Liang X, Liu X, Zhou Y, Wu X, Zhang X, Wang M, Gao Z, Lin T, Cao H, Shen L, Chinese Society Of Clinical Oncology Csco Expert Committee On Gastrointestinal Stromal Tumor. Chinese consensus guidelines for diagnosis and management of gastrointestinal stromal tumor. Chin J Cancer Res. 2017 Aug;29(4):281-293. doi: 10.21147/j.issn.1000-9604.2017.04.01.
PubMed 28947860Dematteo RP, Gold JS, Saran L, Gonen M, Liau KH, Maki RG, Singer S, Besmer P, Brennan MF, Antonescu CR. Tumor mitotic rate, size, and location independently predict recurrence after resection of primary gastrointestinal stromal tumor (GIST). Cancer. 2008 Feb 1;112(3):608-15. doi: 10.1002/cncr.23199.
PubMed 18076015Joensuu H. Risk stratification of patients diagnosed with gastrointestinal stromal tumor. Hum Pathol. 2008 Oct;39(10):1411-9. doi: 10.1016/j.humpath.2008.06.025.
PubMed 18774375Chen H, Xu Z, Huo J, Liu D. Submucosal tunneling endoscopic resection for simultaneous esophageal and cardia submucosal tumors originating from the muscularis propria layer (with video). Dig Endosc. 2015 Jan;27(1):155-8. doi: 10.1111/den.12227. Epub 2014 Jan 20.
PubMed 24444087Standards of Practice Committee; Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc. 2017 Jun;85(6):1117-1132. doi: 10.1016/j.gie.2017.02.022. Epub 2017 Apr 3. No abstract available.
PubMed 28385194Chen T, Xu L, Dong X, Li Y, Yu J, Xiong W, Li G. The roles of CT and EUS in the preoperative evaluation of gastric gastrointestinal stromal tumors larger than 2 cm. Eur Radiol. 2019 May;29(5):2481-2489. doi: 10.1007/s00330-018-5945-6. Epub 2019 Jan 7.
PubMed 30617491Chen Z, Yang J, Sun J, Wang P. Gastric gastrointestinal stromal tumours (2-5 cm): Correlation of CT features with malignancy and differential diagnosis. Eur J Radiol. 2020 Feb;123:108783. doi: 10.1016/j.ejrad.2019.108783. Epub 2019 Dec 11.
PubMed 31841880Kim GH, Ahn JY, Gong CS, Kim M, Na HK, Lee JH, Jung KW, Kim DH, Choi KD, Song HJ, Lee GH, Jung HY. Efficacy of Endoscopic Ultrasound-Guided Fine-Needle Biopsy in Gastric Subepithelial Tumors Located in the Cardia. Dig Dis Sci. 2020 Feb;65(2):583-590. doi: 10.1007/s10620-019-05774-5. Epub 2019 Aug 13.
PubMed 31410755Dumonceau JM, Deprez PH, Jenssen C, Iglesias-Garcia J, Larghi A, Vanbiervliet G, Aithal GP, Arcidiacono PG, Bastos P, Carrara S, Czako L, Fernandez-Esparrach G, Fockens P, Gines A, Havre RF, Hassan C, Vilmann P, van Hooft JE, Polkowski M. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017 Jul;49(7):695-714. doi: 10.1055/s-0043-109021. Epub 2017 May 16.
PubMed 28511234Wu J, Zhuang M, Zhou Y, Zhan X, Xie W. The value of contrast-enhanced harmonic endoscopic ultrasound in differential diagnosis and evaluation of malignant risk of gastrointestinal stromal tumors (<50mm). Scand J Gastroenterol. 2023 May;58(5):542-548. doi: 10.1080/00365521.2022.2144437. Epub 2022 Nov 11.
PubMed 36369879Yang YT, Shen N, Ao F, Chen WQ. Diagnostic value of contrast-enhanced harmonic endoscopic ultrasonography in predicting the malignancy potential of submucosal tumors: a systematic review and meta-analysis. Surg Endosc. 2020 Sep;34(9):3754-3765. doi: 10.1007/s00464-020-07585-6. Epub 2020 Apr 29.
PubMed 32350667Lefort C, Gupta V, Lisotti A, Palazzo L, Fusaroli P, Pujol B, Gincul R, Fumex F, Palazzo M, Napoleon B. Diagnosis of gastric submucosal tumors and estimation of malignant risk of GIST by endoscopic ultrasound. Comparison between B mode and contrast-harmonic mode. Dig Liver Dis. 2021 Nov;53(11):1486-1491. doi: 10.1016/j.dld.2021.06.013. Epub 2021 Jul 14.
PubMed 34272196Lee HS, Cho CM, Kwon YH, Nam SY. Predicting Malignancy Risk in Gastrointestinal Subepithelial Tumors with Contrast-Enhanced Harmonic Endoscopic Ultrasonography Using Perfusion Analysis Software. Gut Liver. 2019 Mar 15;13(2):161-168. doi: 10.5009/gnl18185.
PubMed 30400724Piscaglia F, Nolsoe C, Dietrich CF, Cosgrove DO, Gilja OH, Bachmann Nielsen M, Albrecht T, Barozzi L, Bertolotto M, Catalano O, Claudon M, Clevert DA, Correas JM, D'Onofrio M, Drudi FM, Eyding J, Giovannini M, Hocke M, Ignee A, Jung EM, Klauser AS, Lassau N, Leen E, Mathis G, Saftoiu A, Seidel G, Sidhu PS, ter Haar G, Timmerman D, Weskott HP. The EFSUMB Guidelines and Recommendations on the Clinical Practice of Contrast Enhanced Ultrasound (CEUS): update 2011 on non-hepatic applications. Ultraschall Med. 2012 Feb;33(1):33-59. doi: 10.1055/s-0031-1281676. Epub 2011 Aug 26. No abstract available.
PubMed 21874631
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Harmonic Endoscopic Ultrasound for the Differential Diagnosis Between Gastrointestinal Stromal Tumors and Leiomyomas: A Multicenter Prospective Self-Controlled Study
- ClinicalTrials.gov ID
- NCT07106411
- Acronym / sponsor ID
- CEH-EUS 2025
- Keywords
- Endoscopic ultrasound, Contrast-Enhanced Ultrasonography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Zhongnan Hospital, Wuhan Central Hospital
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Aug 2025 (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.
The investigators conduct a prospective, multicenter diagnostic trial primarily aimed at evaluating the value of contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) in differentiating gastrointestinal stromal tumors (GISTs) from leiomyomas, as well as its predictive utility in the risk stratification of GISTs.
Detailed description
This study adopts a prospective, multicenter, self-controlled (pre-post) design. Patients with upper gastrointestinal subepithelial lesions (SELs) detected under white-light endoscopy will be consecutively enrolled. Each patient will first undergo endoscopic ultrasound (EUS) examination, during which lesion characteristics-including tumor size, margins, internal echogenicity, and originating layer-will be recorded. The contrast-specific extended pure harmonic detection (ExPHD) mode will then be activated, the mechanical index (MI) will be set to 0.3, and 2.4 mL of contrast agent (SonoVue) will be injected intravenously, followed by a 5 mL saline flush. Real-time dynamic imaging will be recorded for 120 seconds, capturing the arterial, venous, and delayed phases.
Histopathological results from surgical or endoscopic resection will serve as the reference standard. The diagnostic performance of EUS and contrast-enhanced EUS (CE-EUS) for differentiating gastrointestinal stromal tumors (GISTs) from leiomyomas and for predicting GIST risk stratification will be compared.
Patients meeting the inclusion criteria will be consecutively recruited. The primary outcome indicators are the sensitivity of CEH-EUS versus EUS in the differential diagnosis between GIST and leiomyoma, as well as in risk stratification of GIST. A prospective, self-controlled design will be used, with a type I error (α) of 0.05 (two-sided) and type II error (β) of 0.20, yielding a power of 0.80. Based on prior studies, the sensitivity of CEH-EUS for differentiating GISTs from leiomyomas is 87%, while that of EUS is approximately 72%-73%. Using McNemar's test for paired binary data (e.g., the same subject evaluated by two methods for positive diagnosis), the minimum sample size required for GIST patients is 121. Given that GISTs account for 67%-68% of all SELs, the required combined sample size of GIST and leiomyoma cases is 178. Accounting for an estimated 20% dropout rate, the final minimum sample size is 222 cases. For the GIST risk stratification analysis, prior studies report a sensitivity of 93% for CEH-EUS and 80% for EUS. McNemar's test was again used for sample size estimation. To meet the statistical requirements, 110 low-risk GIST cases are needed. Considering that low-risk GISTs comprise about 70% of all GISTs, and factoring in a 20% dropout rate, the total number of prospectively enrolled GIST patients required is 196. Since the risk stratification task requires a larger sample size and GISTs are the target of both diagnostic and stratification objectives, the final planned total sample size is 288 patients with GISTs or leiomyomas, which satisfies the statistical requirements for all primary study endpoints.
The study team will screen patients based on inclusion and exclusion criteria, ensure that all necessary examinations are completed to confirm eligibility, and obtain written informed consent from all prospective participants before conducting any study-related procedures.
This is a purely observational study. No additional interventions will be performed on participants, nor will they incur any extra costs. Patient access to optimal diagnostic or therapeutic options will not be affected. The primary potential risk is the breach of patient privacy. A strict data security and monitoring plan will be implemented, and participants will be informed that their data will be used for clinical research purposes.
The diagnostic performance of EUS and CE-EUS in differentiating GISTs from leiomyomas and in risk stratification of GISTs will be compared, with histopathological diagnosis serving as the gold standard. Diagnostic performance will be evaluated using paired analysis. All statistical tests will be two-sided, with significance defined as P < 0.05. Continuous variables will be presented as mean ± standard deviation, and categorical variables as counts and percentages.(1) Diagnostic performance: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the curve (AUC) will be calculated for both CEH-EUS and EUS as interpreted by expert endoscopists. To address class imbalance (e.g., GIST vs. other lesions), F1-score (harmonic mean) and balanced accuracy will also be computed. (2) Continuous variables: Comparisons with baseline will be performed using paired t-tests, analysis of variance (ANOVA), or rank-sum tests, as appropriate to data distribution. (3) Categorical variables: Group comparisons will use Chi-square tests (including Cochran-Mantel-Haenszel Chi-square) or Fisher's exact test. (4) Baseline comparability: Demographic and baseline characteristics will be compared using independent t-tests or Chi-square tests to assess balance between groups. (5) Effectiveness analysis: The primary effectiveness endpoint is the diagnostic accuracy for upper gastrointestinal subepithelial lesions. Differences in proportions and the Youden index will be compared using approximate Z-tests or Chi-square tests, with adjustment for center effects. (6) Statistical software: All statistical analyses will be performed using SPSS version 26.0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Diagnostic Test: Endoscopic Ultrasound, Diagnostic Test: Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)All enrolled patients with upper gastrointestinal subepithelial lesions confirmed by histopathology. Each participant underwent both endoscopic ultrasound (EUS) and contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) examinations. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants aged 18-85 years with gastrointestinal subepithelial lesions identified by endoscopy, undergoing both EUS and CEH-EUS for diagnostic evaluation. Only patients with histologically confirmed GISTs or leiomyomas will be included.
Key inclusion criteria (8 listed)
- Age ≥18 years and ≤ 85 years;
- Subepithelial lesion in the gastrointestinal tract identified under white-light endoscopy and scheduled for CEH-EUS examination to determine the nature of the lesion;
- EUS image quality meets the following quality control standards:
- Patients with GIST confirmed by surgical or endoscopic resection pathology, and patients with leiomyoma confirmed by surgical resection, EUS-guided tissue sampling, or other biopsy techniques;
- Written informed consent is obtained.
Key exclusion criteria (6 listed)
- Age <18 years or >85 years;
- Hemoglobin level ≤8.0 g/dL;
- Known allergy or hypersensitivity to ultrasound contrast agents;
- Pregnant women;
- Severe cardiopulmonary dysfunction that precludes tolerance of endoscopic ultrasound examination;
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 UltrasoundConventional EUS will be performed to evaluate lesion size, echogenicity, border, and layer of origin for differentiation between GISTs and leiomyomas and risk stratification of GISTs. | Diagnostic test | All Participants |
| Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)CEH-EUS will be conducted using a contrast agent to assess vascularity and enhancement patterns of the lesion for differentiation between GISTs and leiomyomas and risk stratification of GISTs. | Diagnostic test | All Participants |
Primary outcome
Diagnostic accuracy of CE-EUS and EUS for differentiating GIST from leiomyoma
Time frame: Within 1 month after final histopathological diagnosis
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.
Accuracy of CE-EUS and EUS in predicting malignant potential (risk stratification) of gastrointestinal stromal tumors
Time frame: Within 1 month after final histopathological diagnosis
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.
3 secondary outcomes
Comparison of CEH-EUS Imaging Characteristics Between GIST and Leiomyoma
Time frame: Within 1 month after histopathological diagnosis
Quantitative TIC Parameter Analysis for Differential Diagnosis and Risk Stratification
Time frame: Within 1 month after histopathological diagnosis
Correlation of CEH-EUS Perfusion Parameters with Tumor Type and Risk Classification
Time frame: Within 1 month after histopathological diagnosis
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 6 Aug 2025.
- Results publication: PubMed 36470211Abe K, Tominaga K, Yamamiya A, Inaba Y, Kanamori A, Kondo M, Suzuki T, Watanabe H, Kawano M, Sato T, Yoshitake N, Ohwada T, Konno M, Hanatsuka K, Masuyama H, Goda K, Haruyama Y, Irisawa A; NUTSHELL20 Study group. Natural History of Small Gastric Subepithelial Lesions Less than 20 mm: A Multicenter Retrospective Observational Study (NUTSHELL20 Study). Digestion. 2023;104(3):174-186. doi: 10.1159/000527421. Epub 2022 Dec 5.
- Results publication: PubMed 28947860Li J, Ye Y, Wang J, Zhang B, Qin S, Shi Y, He Y, Liang X, Liu X, Zhou Y, Wu X, Zhang X, Wang M, Gao Z, Lin T, Cao H, Shen L, Chinese Society Of Clinical Oncology Csco Expert Committee On Gastrointestinal Stromal Tumor. Chinese consensus guidelines for diagnosis and management of gastrointestinal stromal tumor. Chin J Cancer Res. 2017 Aug;29(4):281-293. doi: 10.21147/j.issn.1000-9604.2017.04.01.
- Results publication: PubMed 18076015Dematteo RP, Gold JS, Saran L, Gonen M, Liau KH, Maki RG, Singer S, Besmer P, Brennan MF, Antonescu CR. Tumor mitotic rate, size, and location independently predict recurrence after resection of primary gastrointestinal stromal tumor (GIST). Cancer. 2008 Feb 1;112(3):608-15. doi: 10.1002/cncr.23199.
- Results publication: PubMed 18774375Joensuu H. Risk stratification of patients diagnosed with gastrointestinal stromal tumor. Hum Pathol. 2008 Oct;39(10):1411-9. doi: 10.1016/j.humpath.2008.06.025.
- Results publication: PubMed 24444087Chen H, Xu Z, Huo J, Liu D. Submucosal tunneling endoscopic resection for simultaneous esophageal and cardia submucosal tumors originating from the muscularis propria layer (with video). Dig Endosc. 2015 Jan;27(1):155-8. doi: 10.1111/den.12227. Epub 2014 Jan 20.
- Results publication: PubMed 28385194Standards of Practice Committee; Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc. 2017 Jun;85(6):1117-1132. doi: 10.1016/j.gie.2017.02.022. Epub 2017 Apr 3. No abstract available.
- Results publication: PubMed 30617491Chen T, Xu L, Dong X, Li Y, Yu J, Xiong W, Li G. The roles of CT and EUS in the preoperative evaluation of gastric gastrointestinal stromal tumors larger than 2 cm. Eur Radiol. 2019 May;29(5):2481-2489. doi: 10.1007/s00330-018-5945-6. Epub 2019 Jan 7.
- Results publication: PubMed 31841880Chen Z, Yang J, Sun J, Wang P. Gastric gastrointestinal stromal tumours (2-5 cm): Correlation of CT features with malignancy and differential diagnosis. Eur J Radiol. 2020 Feb;123:108783. doi: 10.1016/j.ejrad.2019.108783. Epub 2019 Dec 11.
- Results publication: PubMed 31410755Kim GH, Ahn JY, Gong CS, Kim M, Na HK, Lee JH, Jung KW, Kim DH, Choi KD, Song HJ, Lee GH, Jung HY. Efficacy of Endoscopic Ultrasound-Guided Fine-Needle Biopsy in Gastric Subepithelial Tumors Located in the Cardia. Dig Dis Sci. 2020 Feb;65(2):583-590. doi: 10.1007/s10620-019-05774-5. Epub 2019 Aug 13.
- Results publication: PubMed 28511234Dumonceau JM, Deprez PH, Jenssen C, Iglesias-Garcia J, Larghi A, Vanbiervliet G, Aithal GP, Arcidiacono PG, Bastos P, Carrara S, Czako L, Fernandez-Esparrach G, Fockens P, Gines A, Havre RF, Hassan C, Vilmann P, van Hooft JE, Polkowski M. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017 Jul;49(7):695-714. doi: 10.1055/s-0043-109021. Epub 2017 May 16.
- Results publication: PubMed 36369879Wu J, Zhuang M, Zhou Y, Zhan X, Xie W. The value of contrast-enhanced harmonic endoscopic ultrasound in differential diagnosis and evaluation of malignant risk of gastrointestinal stromal tumors (<50mm). Scand J Gastroenterol. 2023 May;58(5):542-548. doi: 10.1080/00365521.2022.2144437. Epub 2022 Nov 11.
- Results publication: PubMed 32350667Yang YT, Shen N, Ao F, Chen WQ. Diagnostic value of contrast-enhanced harmonic endoscopic ultrasonography in predicting the malignancy potential of submucosal tumors: a systematic review and meta-analysis. Surg Endosc. 2020 Sep;34(9):3754-3765. doi: 10.1007/s00464-020-07585-6. Epub 2020 Apr 29.
- Individual participant dataSharing planned: No
Related trials for Submucosal Tumor
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Recruiting
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Pancreatic Disease, Pancreatic Cancer
Not yet recruitingObservational study
Follow-up After Oncological Resection by Endoscopic Colorectal ESD (Endoscopic Submucosal Dissection)
Colorectal Neoplasms
Active, not recruiting
Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection
Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia
Not yet recruiting
Traction-Assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors
Rectal Neuroendocrine Tumor
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.
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 Submucosal Tumor and Gastrointestinal Stromal Tumor (GIST), run by Huazhong University of Science and Technology at 1 site in China.
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 8 inclusion and 6 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 6 Aug 2025. 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 China. 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 Bin Cheng (13986097542, b.cheng@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CE-EUS and EUS for differentiating GIST from leiomyoma (time frame: Within 1 month after final histopathological diagnosis). The study lists 2 primary outcomes in all. 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 NCT07106411, which also lists 17 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 6 Aug 2025.