Prevalence and endoscopic predictioN of sessile serrated lesion with dysplasia and submucosal Invasive cancer in large sessile lesions

Prevalence and endoscopic predictioN of sessile serrated lesion with dysplasia and submucosal Invasive cancer in large sessile lesions - Prevalence and endoscopic predictioN of sessile serrated lesion with dysplasia and submucosal Invasive cancer in large sessile lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056765

Enrollment

482

Registered

2025-01-21

Start date

2025-04-01

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

Serrated lesions larger than 20 mm

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with endoscopically diagnosed serrated lesions larger than 20mm 2. 18 years or older at the time of consent 3. Written informed consent obtained from the patient

Exclusion criteria

Exclusion criteria: 1. Residual/recurrent lesions previously attempted for endoscopic resection 2. Patients with inflammatory bowel disease 3. Patients with polyposis syndrome 4. Pregnant women or those planning pregnancy during the study period 5. Patients deemed inappropriate for the study by the principal investigator

Design outcomes

Primary

Measure	Time frame
Negative predictive value of endoscopic assessment for submucosal invasive cancer in SL lesions	—

Secondary

Measure	Time frame
1. Negative predictive value of endoscopic assessment for SSLD 2. Prevalence of SSLD/submucosal invasive cancer in endoscopically diagnosed SSL lesions 3. Proportion of endoscopically diagnosed SSL among pathologically confirmed SSL 4. Correlation between endoscopic features (nodularity/double elevation/central depression) and SSLD/invasive cancer location 5. Sensitivity of endoscopic diagnosis for pathological SSLD/submucosal invasive cancer 6. Adverse event rate (delayed bleeding, perforation)	—

Measure

Time frame

1. Negative predictive value of endoscopic assessment for SSLD 2. Prevalence of SSLD/submucosal invasive cancer in endoscopically diagnosed SSL lesions 3. Proportion of endoscopically diagnosed SSL among pathologically confirmed SSL 4. Correlation between endoscopic features (nodularity/double elevation/central depression) and SSLD/invasive cancer location 5. Sensitivity of endoscopic diagnosis for pathological SSLD/submucosal invasive cancer 6. Adverse event rate (delayed bleeding, perforation)

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Countries

Japan

Contacts

Public ContactTaishi Okumura

Showa University Northern Yokohama Hospital Digestive Disease Center

javier.thierry@gmail.com81-45-949-7000

Outcome results