multi-center prospective study for cancer-bearing rate of gastric low-grade intraepithelial neoplasia

multi-center prospective study for cancer-bearing rate of gastric low-grade intraepithelial neoplasia - multi-center prospective study for cancer-bearing rate of gastric low-grade intraepithelial neoplasia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007476

Enrollment

100

Registered

2012-03-12

Start date

2012-03-01

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

gastric low-grade intraepithelial neoplasia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) To be diagnosed as category 3 of Vienna classification (equivalent to Group 3 (and Group 4) of Japanese Classification of Gastric Carcinoma March 2010 (The 14th Edition)) pathologically by endoscopic forceps specimen. 2) Not to be accompanied with ulcer. 3) age >= 20 years old. 4) Written informed consent has been obtained.

Exclusion criteria

Exclusion criteria: 1) To have bleeding tendency. 2) Unable to interrupt anticoaglant for ER. 3) To be judged inapropriate to participate this trial by contact person.

Design outcomes

Primary

Measure	Time frame
The proportion of patients diagnosed as cancer after ER by central review among patients with category 3 of Vienna classification diagnosed by endoscopic forceps biopsy specimen by central review.	—

Secondary

Measure	Time frame
1) The proportion of patients diagnosed as cancer after ER by central review of histology among all included patients. 2) The short-term outcomes of ER. Rate of adverse event (based on NCI-CTCAE ver. 4.0) En bloc margin negative rate of ESD Procedure duration 3) Histological findings of resected specimen. histological type presence or absence of vessels involvement horizontal and vertical margin 4) Endoscopic findings. macroscopic type (based on Paris classification) the size of lesion color surface pattern the findings of NBI Magnified Endoscopy	—

Measure

Time frame

1) The proportion of patients diagnosed as cancer after ER by central review of histology among all included patients. 2) The short-term outcomes of ER. Rate of adverse event (based on NCI-CTCAE ver. 4.0) En bloc margin negative rate of ESD Procedure duration 3) Histological findings of resected specimen. histological type presence or absence of vessels involvement horizontal and vertical margin 4) Endoscopic findings. macroscopic type (based on Paris classification) the size of lesion color surface pattern the findings of NBI Magnified Endoscopy

—

Countries

Japan

Contacts

Public ContactTsutomu Nishida

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology

tnishida@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results