UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060687 |
|---|---|
| Receipt number | R000069413 |
| Scientific Title | A knowledge-generating multicenter prospective study: intraoperative near-infrared fluorescence ureteral navigation-guided dissection in oncologically difficult colorectal cancer surgery |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/19 13:27:35 |
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Basic information
Public title
A knowledge-generating multicenter prospective study: intraoperative near-infrared fluorescence ureteral navigation-guided dissection in oncologically difficult colorectal cancer surgery
Acronym
the KINGDOM study
Scientific Title
A knowledge-generating multicenter prospective study: intraoperative near-infrared fluorescence ureteral navigation-guided dissection in oncologically difficult colorectal cancer surgery
Scientific Title:Acronym
the KINGDOM study
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the multifaceted clinical significance of fluorescent ureteral navigation (FUN) in colorectal cancer surgery by prospectively collecting multicenter data on treatment outcomes using near-infrared fluorescence ureteral catheters or the IRIS U Kit. Specifically, we will assess the impact of FUN on the incidence of ureteral injury, conversion to open surgery, R0 resection rate, pathological circumferential resection margin positivity rate, incidence of adverse events, and surgeon workload.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
the incidence of ureteral injury
Key secondary outcomes
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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Shunjin |
| Middle name | |
| Last name | Ryu |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Digestive Surgery
Zip code
333-0833
Address
180, Nishiaraijuku, Kawaguchi City, Saitama, Japan
TEL
048-287-2525
systematic.ryu1121@gmail.com
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Kondo |
Organization
Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
761-0893
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2438
Homepage URL
kondo.akihiro.z4@kagawa-u.ac.jp
Sponsor or person
Institute
Kawaguchi Municipal Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Fluorescence Guided Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Kagawa University
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel
087-891-2011
kenkyushien-m@kagawa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrollment period: From the date of study approval to March 31, 2028.
Observation period for each participant: From the date of study approval to June 30, 2028.
Planned study completion date: March 31, 2031.
Management information
Registered date
| 2026 | Year | 02 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069413
