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Validation of the Utility of Indocyanine Green for Fluorescence Imaging in Pediatric Gastrointestinal Surgery

Evaluation of the usefulness of a fluorescence imaging system using indocyanine green during pediatric gastrointestinal surgery.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031230519
Enrollment
60
Registered
2023-12-19
Start date
2023-12-19
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

neonatal gastrointestinal perforation, necrotizing enterocolitis, congenital intestinal atresia, eso necrotizing enterocolitis

Interventions

During pediatric gastrointestinal surgery, 0.1-0.2 mg/kg of ICG is injected to determine the extent of intestinal resection. If the blood flow is normal, ICG distribution in the intestinal tract is ob
C492448

Sponsors

Takeda Masahiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who require pediatric gastrointestinal surgery at the time of consent (neonatal gastrointestinal perforation, necrotizing enterocolitis, congenital intestinal atresia, esophageal atresia, Hirschsprung's disease, anal fistula, etc.) (2) Subjects who have received a thorough explanation of their participation in this study, and who have obtained the free and voluntary written consent of the research subject's surrogate after full understanding of the subject's condition.

Exclusion criteria

Exclusion criteria: (1) Those who could not give their consent to participate in the research (2) Other persons deemed inappropriate as research subjects by the principal investigator

Design outcomes

Primary

MeasureTime frame
The postoperative complications (anastomotic suture failure, anastomotic stenosis, and colostomy problems) will be evaluated and observed as evaluation items in the postoperative follow-up. Observation methods will be the same as those used in general medical care, and the frequency of examination will not be increased as a result of participation in this study.

Contacts

Public ContactMasahiro Takeda

Juntendo University School of Medicine

mstakeda@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

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