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Assessment of feasibility of sentinel node mapping by indocyanine green fluorescence imaging and metastatic diagnosis by one-step nucleic acid amplification in laparoscopic gastric cancer surgery

Assessment of feasibility of sentinel node mapping by indocyanine green fluorescence imaging and metastatic diagnosis by one-step nucleic acid amplification in laparoscopic gastric cancer surgery - Assessment of validity of sentinel node mapping by indocyanine green fluorescence imaging in laparoscopic gastric cancer surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021171
Enrollment
20
Registered
2016-02-25
Start date
2016-08-01
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

Early gastric cancer

Interventions

To detect sentinel nodes, the tracer (indocyanine green solution) is administrated to the submucosa around the primary tumor at the beginning of surgery. Stained/fluorescent nodes are harvested intr

Sponsors

Cancer Institute Hospital, Japanese Foundation for Cancer Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) age >= 20 2) clinically T1N0M0 gastric cancer 3) single lesion 4) less than 4cm in diameter 5) out of indication for endoscopic resection 6) biopsy from the primary lesion is positive for CK19 7) BMI <=25 8) The patient who give prior concent to join this study 9) the type of biopsy specimen does not matter

Exclusion criteria

Exclusion criteria: 1) the past history of gastric resection or the endoscope treatment 2) the case with tumor invading to esophagus or duodenum 3) a pregnant woman, patients having drug (iodo) allergy career or the asthma 4) the case which the physician judged as the inappropriate case to participate in this study

Design outcomes

Primary

MeasureTime frame
identification rate of fluorescent nodes

Secondary

MeasureTime frame
1)Durations of tracer administration, sentinel node mapping and diagnosis by one-step nucleic acid amplification. 2)Number of detected sentinel nodes 3)Distribution of sentinel nodes 4)Incidence rate of adverse events and postoperative complications

Countries

Japan

Contacts

Public ContactKoshi Kumagai

Cancer Institute Hospital, Japanese Foundation for Cancer Research Gastroenterological surgery

koshi.kumagai@jfcr.or.jp03-3520-0111

Outcome results

None listed

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