A knowledge-generating multicenter prospective study: intraoperative near-infrared fluorescence ureteral navigation-guided dissection in oncologically difficult colorectal cancer surgery

A knowledge-generating multicenter prospective study: intraoperative near-infrared fluorescence ureteral navigation-guided dissection in oncologically difficult colorectal cancer surgery - the KINGDOM study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060687

Enrollment

330

Registered

2026-04-01

Start date

2026-09-01

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

Colorectal Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with colorectal cancer (including appendix, rectum, and anus) histologically diagnosed as malignant tumors (pap, tub, por, muc, sig, or med). 2. Patients aged between 18 and 85 years. 3. Patients judged by the attending physician to be at high risk of ureteral injury. 4. Patients undergoing surgery using fluorescent ureteral navigation (FUN) with either the NIRC fluorescent ureteral catheter or the IRIS U Kit. 5. Patients scheduled for minimally invasive surgery (laparoscopic or robot-assisted). 6. Patients who have received a full explanation of the study, have sufficient understanding, and have provided written informed consent of their own free will prior to participation.

Exclusion criteria

Exclusion criteria: 1. Patients requiring emergency surgery. 2. Patients scheduled to undergo open surgery or planned intraoperative conversion to open surgery (excluding laparotomy for reconstruction purposes). 3. Patients with severe comorbidities (e.g., cardiac disease, pulmonary disease, bleeding tendency, or poorly controlled hypertension or diabetes mellitus). 4. Patients deemed inappropriate for inclusion in the study by the principal investigator or sub-investigators.

Design outcomes

Primary

Measure	Time frame
the incidence of ureteral injury	—

Secondary

Measure	Time frame
1. Incidence of ureter-related complications within 90 days postoperatively 2. Incidence of postoperative complications within 30 days 3. Conversion rate to open surgery 4. The rate of positive circumferential resection margin in rectal cancer cases 5. R0 resection rate 6. Surgeon-reported subjective usefulness score (questionnaire on fluorescence visibility and utility, and NASA Raw Task Load Index [TLX] score)	—

Measure

Time frame

1. Incidence of ureter-related complications within 90 days postoperatively 2. Incidence of postoperative complications within 30 days 3. Conversion rate to open surgery 4. The rate of positive circumferential resection margin in rectal cancer cases 5. R0 resection rate 6. Surgeon-reported subjective usefulness score (questionnaire on fluorescence visibility and utility, and NASA Raw Task Load Index [TLX] score)

—

Countries

Japan

Contacts

Public ContactAkihiro Kondo

Kagawa University Department of Gastroenterological Surgery

kondo.akihiro.z4@kagawa-u.ac.jp087-891-2438

Outcome results