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Multicenter randomized controlled trial comparing the diagnostic performance of the submucosal invasion between chromoendoscopy and endoscopic ultrasonography

Multicenter randomized controlled trial comparing the diagnostic performance of the submucosal invasion between chromoendoscopy and endoscopic ultrasonography - NES vs EUS trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048766
Enrollment
300
Registered
2022-08-29
Start date
2022-09-05
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 cancer

Interventions

In the chromoendoscopy group, diagnosis of depth of invasion of early gastric cancer was first performed using chromoendoscopy. Immediately after that, the same examiner diagnoses the depth of inavasi

Sponsors

Fukuoka University Chikushi Hospital
Lead Sponsor
Osaka internatinal Cancer Institute Tobata Kyoritsu Hospital Kochi Red Cross Hospital Ishikawa Prefectural Central Hospital Kyoto Prefectural University of Medicine
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients diagnosed with early gastric cancer by endoscopic diagnosis and diagnosed as Category 4 or 5 of the Vienna classification 2 Patients with a tumor diameter of 10 mm or more, and in the case of multiple lesions, the lesion with the largest tumor diameter is targeted 3 Patients scheduled for endoscopic resection or surgical resection 4 Patients aged 20 years or older on the date of registration

Exclusion criteria

Exclusion criteria: 1 Patients after gastrectomy 2 Pedunculated gastric cancer 3 Patients planning preoperative chemotherapy 4 Patients who are deemed unsuitable for this study by their attending physician or examination physician

Design outcomes

Primary

MeasureTime frame
The primary endopoint of this study is the specificity of diagnosis of depth of invasion of early gastric cancer by chromoendoscopy using non-extension sign and diagnosis of depth of invasion of early gastric cancer using endoscopic ultrasonography for diagnosing cT1b or deeper in the protocol initial examination.

Countries

Japan

Contacts

Public ContactMasaki Miyaoka

Fukuoka University Chikushi Hospital Endoscopy

miyaoka1@fukuoka-u.ac.jp092-921-1011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026