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

JRCT ID: jRCT1031230519

Registered date:19/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: neonatal gastrointestinal perforation, necrotizing enterocolitis, congenital intestinal atresia, eso
• Date of first enrollment: 19/12/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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 observed in 20-30 seconds using a fluorescent imaging system, and the area with poor ICG distribution is judged to be inappropriate for intestinal anastomosis or colostomy, and is resected.
In the postoperative follow-up, complications after surgery (such as anastomotic leakage, anastomotic stricture, and issues with stoma) are set as evaluation items and observed. The observation method follows general medical care, and there are no changes in examination frequency due to participation in this study.

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Takeda Masahiro