Feasibility of sentinel node mapping as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial

Feasibility of sentinel node mapping as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial - Feasibility of sentinel node as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010458

Enrollment

Registered

2013-04-10

Start date

2013-05-01

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

Gastric cancer following endoscopic resection

Interventions

Gastrectomy and lymphadenectomy according to the Japanese guideline with dual tracer method using a radioactive colloid and blue dye

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with a single tumor <4cm in diameter required additional surgery following endoscopic resection. 1) Pathological T1a (M), differentiated-type adenocarcinoma with ulceration, 3 cm< 2) pT1a (M), undifferentiated-type without ulceration, 2cm< 3) pT1a (M), undifferentiated-type with ulceration 4) pT1b (SM1) differentiated-type without ulceration, 3cm< 5) pT1b (SM1) with ulceration 6) pT1b (SM2/3) 7) vascular invasion positive 8) resection margin positive Within 3 months from endoscopic resection to surgery Written informed consent

Exclusion criteria

Exclusion criteria: Pregnancy Past history of severe drug allergy Asthma Active other primary malignancies Patients whom doctors judged inadequate to the enrollment of this study by other reasons Gastric remnant cancer

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy for lymph node metastases	—

Secondary

Measure	Time frame
Detection rate Distribution Sensitivity Adverse events	—

Countries

Japan

Contacts

Public ContactHiroya Takeuchi

School of Medicine, Keio University Department of Surgery

htakeuchi@a6.keio.jp03-5363-3802

Outcome results

None listed

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