Evaluating the Diagnostic Accuracy and Safety of Endoscopic Ultrasound (EUS) Using a Gel for Early Colorectal Cancer Staging: A Multicenter Prospective Observational Study.

Evaluating the Diagnostic Accuracy and Safety of Endoscopic Ultrasound (EUS) Using a Gel for Early Colorectal Cancer Staging: A Multicenter Prospective Observational Study. - Evaluating the Diagnostic Accuracy and Safety of Endoscopic Ultrasound (EUS) Using a Gel for Early Colorectal Cancer Staging: A Multicenter Prospective Observational Study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061153

Enrollment

134

Registered

2026-05-01

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Colorectal Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Selection (Inclusion) Criteria: Patients must meet all of the following criteria: (1) Colorectal neoplastic lesions diagnosed as JNET Type 2B. (2) Lesions measuring 5 to 30 mm in diameter. (3) Patients expected to undergo endoscopic or surgical treatment within 3 months after the Gel-EUS examination. (4) Patients aged 20 to 90 years at the time of informed consent acquisition. (5) Patients with a Performance Status (PS; ECOG) of 0, 1, or 2. (6) Gender is not a factor (Irrespective of gender). (7) Patients who have provided voluntary written informed consent from themselves or a legally acceptable representative.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will not be included in this study: (1) Lesions diagnosed as cT2 cancer or deeper on conventional and magnifying endoscopic observation. (2) Lesions diagnosed as an adenoma on conventional and magnifying endoscopic observation. (3) Lesions with a macroscopic type of 0-Ip (pedunculated type). (4) Residual or recurrent lesions after prior endoscopic treatment. (5) Patients with a complication or history of inflammatory bowel disease (IBD). (6) Patients with colonic polyposis. (7) Females who are pregnant or have the potential to become pregnant. (8) Patients who have a history of prior registration in this study. (9) Cases judged to be inappropriate for participation in this study by the Principal Investigator or Sub-investigator.

Design outcomes

Primary

Measure	Time frame
Specificity for the differential diagnosis of cTis, cT1.	—

Secondary

Measure	Time frame
Accuracy, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) for the diagnosis of cTis, cT1. Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for diagnosing a VM (distance from the tumor invasion front to the muscularis propria) of >= 500 um in endoscopically or surgically resected specimens, based on the Tumor-free distance (EUS-TFD) classification (Type I: EUS-TFD >= 1 mm vs. Type II: EUS-TFD < 1 mm).	—

Measure

Time frame

Accuracy, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) for the diagnosis of cTis, cT1. Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for diagnosing a VM (distance from the tumor invasion front to the muscularis propria) of >= 500 um in endoscopically or surgically resected specimens, based on the Tumor-free distance (EUS-TFD) classification (Type I: EUS-TFD >= 1 mm vs. Type II: EUS-TFD < 1 mm).

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Countries

Japan

Contacts

Public ContactToshio Kuwai

Hiroshima University Hospital Gastrointestinal Endoscopy and Medicine

kuwai@hiroshima-u.ac.jp082-257-5193

Outcome results