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A clinical trial to evaluate the feasibility of patient-specific perigastric lymph node dissection (tailored surgery) using indocyanine green fluorescence navigation in gastric cancer surgery

A clinical trial to evaluate a feasibility of the Fluorescent ICG-guided Tailored gastrectomy by Illuminating lymph Node basin (FITIN)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005760
Enrollment
200
Registered
2021-01-11
Start date
2021-04-23
Completion date
Unknown
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Submucosal injection of indocyanine green through an intraoperative gastroscope so that the swollen areas of the submucosal injection are in contact with each other around entire gastric cancer

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? 20 years old ~ 90 years old ? Patients confirmed to be able to proceed and manage general surgery in the usual preoperative evaluation ? Single gastric cancer less than 4cm in diameter with clinical stage cT1-3NanyM0. Including additional surgery after incomplete endoscopic resection ? Gastric cancer patients scheduled for radical minimally invasive gastric cancer surgery ? Subjects who heard the explanation of the study and gave written consent

Exclusion criteria

Exclusion criteria: ? Multiple synchronous gastric cancer ? Stomach or esophagus varix or liver cirrhosis of Child-Pugh class B or higher ? During pregnancy ? History of hypersensitivity to indocyanine green ? Iodine intolerance ? History of gastric cancer surgery ? When distant metastasis or peri organ invasion was noticed during the diagnostic laparoscopy ? When severe adhesion was noticed during the diagnostic laparoscopy

Design outcomes

Primary

MeasureTime frame
The rate at which the fluorescence signal from the lymph node area predicts lymph node metastasis

Secondary

MeasureTime frame
The theoretically possible ratio of function preserved reduced surgery, assuming that surgery based on fluorescence signals is performed.

Countries

Korea, Republic of

Contacts

Public ContactSeong-Ho Kong

Seoul National University Hospital

wisehearted@gmail.com+82-2-2072-2318

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026