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A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.

A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye. - A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015310
Enrollment
700
Registered
2014-11-01
Start date
2012-12-21
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

Esophageal cancer/ Gastric cancer

Interventions

We use radioisotope and blue stain as a tracer, and perform SN mapping. We diagnose metastasis of SN by intraoperative and frozen tissue examination.

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age 20 to 80 2) Esophageal cancer or gastric cancer patients with no nodal metastasis nor distant metastasis. 3) Tumor with single lesion. 4) Provided with written informed conscent. 5) Histopathological results does not matter.

Exclusion criteria

Exclusion criteria: 1) Pregnancy, severe drug allergy, asthoma. 2) Multiple tumor lesion or with synchronous or metachronous (within 5 years) malignancies. 3) With prior endoscopic treatment to same lesion. 4) Judged as irrelevant object for this study 5) Refusal of the trial entry 6) Absolute indication for endoscopic treatments

Design outcomes

Primary

MeasureTime frame
Accuracy of nodal evaluation of metastasis based on sentinel node biopsy.

Secondary

MeasureTime frame
Number of identified SNs, Detection rate of sentinel nodes, sensitivity to detect lymph node metastasis based on sentinel node biopsy, negative predictive value of lymph node metastasis.

Countries

Japan

Contacts

Public ContactKazumasa Fukuda

Keio University, School of Medicine Department of Surgery

fukudak@z6.keio.jp03-3353-1211

Outcome results

None listed

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