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Evaluation of new clinical application to tissue perfusion of digestive surgery using indocyanine green (ICG) enhanced fluorescence system

Evaluation of new clinical application to tissue perfusion of digestive surgery using indocyanine green (ICG) enhanced fluorescence system - Evaluation of new clinical application to tissue perfusion of digestive surgery using indocyanine green (ICG) enhanced fluorescence system

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030747
Enrollment
100
Registered
2018-01-11
Start date
2015-12-18
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Digestive disease

Interventions

To investigate blood supply of gastrointestinal tract tissue, ICG intravenous injection during operation was performed using ICG solution at a concentration of 5 mg/ml. Anostomoses were observed for f
Co. KG, Tuttlingen, Germany) was used to generate ICG-enhanced fluorescence images.

Sponsors

Teikyo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria are as follow: 20 and more than 20 years old, undergoing digestive surgery operation, and requiring to provide written informed concent before enrolment.

Exclusion criteria

Exclusion criteria: Exclusion criteria are as follow: having an allergy to ICG or iodine, pregnant or breastfeeding woman, being concidered as ineligible, and retraction of the concent.

Design outcomes

Primary

MeasureTime frame
Safety of the measurement of blood supply in anastomotic tissue using ICG-enhanced fluorescence system: incidence rate of intraoperative or postoperative complication related to ICG injection.

Secondary

MeasureTime frame
Clinical outcomes: incidence rate of postoperative complication, severity assessment of postoperative complication by Clavien-Dindo classification system, and postoperative hospital stay, mortality.

Countries

Japan

Contacts

Public ContactKiyohiko Shuto

Teikyo University Chiba Medical Center Department of Surgery

kshuto@med.teikyo-u.ac.jp0436-62-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026